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A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nevirapine
Zidovudine
Zalcitabine
Didanosine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Nevirapine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis. Allowed: Erythropoietin maintenance. G-CSF and GM-CSF. Prophylaxis for Mycobacterium avium intracellulare. Antifungal prophylaxis or treatment with specific drugs. Maintenance therapy for opportunistic infection. Over-the-counter medications or alternative therapies such as vitamins and herbs. Antibiotics as clinically indicated. Steroids for < 21 days for acute problems. Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications. Concurrent Treatment: Allowed: Radiation therapy for cutaneous Kaposi's sarcoma. Acupuncture. Patients must have: Documented HIV infection. CD4 count <= 50 cells/mm3. Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance. Life expectancy of at least 6 months. Consent of parent or guardian if < 18 years of age. Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment). NOTE: Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Abnormal baseline chest x-ray. New pulmonary or cardiac symptoms. Psychological or emotional problems sufficient to prevent compliance with study medication. Concurrent Medication: Excluded: Systemic chemotherapy for malignancy. Acute or induction therapy for opportunistic infection. Antiretroviral drugs other than study drugs. Biological response modifiers. Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin. Patients with the following prior conditions are excluded: History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. Evidence of active pulmonary disease within 6 months prior to study entry. History of grade 3 or worse peripheral neuropathy. History of acute or chronic pancreatitis. Prior Medication: Excluded: Prior nevirapine. Excluded within 7 days prior to study entry: Acute therapy for opportunistic infection (maintenance therapy is permitted). Acute systemic therapy for a nonopportunistic infection or other medical condition. Antiretroviral drugs other than AZT, ddI, or ddC. Biological response modifiers. d4T therapy. Nucleosides other than those used in the study. Antibiotics containing clavulanate potassium. Prior Treatment: Excluded: More than 4 units of blood in a 30-day period. Active alcohol or drug abuse.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Children's Hosp of Los Angeles
  • Univ of Southern California / LA County USC Med Ctr
  • Huntington Memorial Hosp / Children's Hosp of Los Angeles
  • Univ of California / San Diego Treatment Ctr
  • San Francisco AIDS Clinic / San Francisco Gen Hosp
  • San Francisco Gen Hosp
  • Stanford at Kaiser / Kaiser Permanente Med Ctr
  • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
  • San Mateo AIDS Program / Stanford Univ
  • Stanford Univ Med Ctr
  • Olive View Med Ctr
  • Harbor UCLA Med Ctr
  • Denver Dept of Health and Hosps
  • Mountain States Reg Hemo Ctr / Univ of Colorado
  • Rose Med Ctr
  • Univ of Colorado Health Sciences Ctr
  • Yale Univ / New Haven
  • HIV Ctr - District of Columbia Gen Hosp
  • Whitman - Walker Clinic / Georgetown Univ Med Ctr
  • Georgetown Univ Med Ctr
  • George Washington Univ / Hershey Med Ctr
  • Howard Univ
  • Univ of Miami School of Medicine
  • Univ of South Florida
  • Univ of Hawaii
  • Northwestern Univ Med School
  • Cook County Hosp
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Louis A Weiss Memorial Hosp
  • Indiana Univ Hosp
  • Methodist Hosp of Indiana / Life Care Clinic
  • Univ of Louisville / East Tennesee Comprehensive Hem Ctr
  • Harvard (Massachusetts Gen Hosp)
  • Boston Med Ctr
  • Beth Israel Deaconess - West Campus
  • Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
  • Hennepin County Med Clinic
  • Univ of Minnesota
  • St Paul Ramsey Med Ctr
  • St Louis Regional Hosp / St Louis Regional Med Ctr
  • Univ of Nebraska Med Ctr
  • Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
  • Robert Wood Johnson Med School / Hershey Med Ctr
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Adirondack Med Ctr at Saranac Lake
  • Albany Med College / Division of HIV Medicine A158
  • Mid - Hudson Care Ctr
  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  • Comprehensive Health Care Ctr / Bronx Municipal Hosp
  • Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
  • Montefiore Family Health Ctr / Bronx Municipal Hosp
  • Samaritan Village Inc / Bronx Municipal Hosp
  • Jack Weiler Hosp / Bronx Municipal Hosp
  • Montefiore Med Ctr / Bronx Municipal Hosp
  • Montefiore Med Ctr Adolescent AIDS Program
  • North Central Bronx Hosp / Bronx Municipal Hosp
  • Bronx Veterans Administration / Mount Sinai Hosp
  • SUNY / Health Sciences Ctr at Brooklyn
  • SUNY / Erie County Med Ctr at Buffalo
  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp
  • North Shore Univ Hosp
  • Beth Israel Med Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Saint Clare's Hosp and Health Ctr
  • Cornell Univ Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Mount Sinai Med Ctr / Hemophilia Treatment Ctr
  • Mount Sinai Med Ctr
  • Columbia Presbyterian Med Ctr
  • Harlem Hosp Ctr
  • Univ of Rochester Medical Center
  • SUNY / State Univ of New York
  • Univ of North Carolina
  • Moses H Cone Memorial Hosp
  • Univ of Cincinnati
  • Univ of Kentucky Lexington
  • Case Western Reserve Univ
  • MetroHealth Med Ctr
  • Columbus Children's Hosp
  • Med College of Ohio
  • Milton S Hershey Med Ctr
  • Saint Michael's Med Ctr / Milton S Hershey Med Ctr
  • Girard Med Ctr
  • Univ of Pennsylvania at Philadelphia
  • Thomas Jefferson Univ Hosp
  • Med Univ of South Carolina / UNC
  • Julio Arroyo
  • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
  • Meharry Med College
  • Univ of Texas Galveston
  • Univ Texas Health Science Ctr / Univ Texas Med School
  • Univ of Washington
  • Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
  • Great Lakes Hemophilia Foundation
  • Univ of Puerto Rico

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000781
Brief Title
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
Official Title
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease. The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
Detailed Description
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity. Patients are randomized to receive either AZT/ddC, AZT/ddI, AZT alternating monthly with ddI, or AZT/ddI/nevirapine. Patients are evaluated at week 0 and every 4 weeks thereafter for 2 years. Pharmacologic, virologic, and macroneurologic substudies will be conducted. Patients who are already enrolled on protocol ACTG 193 will be given the option of continuing on their originally assigned ACTG 193 therapy for an additional 6 months or undergoing re-randomization to one of the four treatment arms on ACTG 193A.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Nevirapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
1292 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis. Allowed: Erythropoietin maintenance. G-CSF and GM-CSF. Prophylaxis for Mycobacterium avium intracellulare. Antifungal prophylaxis or treatment with specific drugs. Maintenance therapy for opportunistic infection. Over-the-counter medications or alternative therapies such as vitamins and herbs. Antibiotics as clinically indicated. Steroids for < 21 days for acute problems. Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications. Concurrent Treatment: Allowed: Radiation therapy for cutaneous Kaposi's sarcoma. Acupuncture. Patients must have: Documented HIV infection. CD4 count <= 50 cells/mm3. Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance. Life expectancy of at least 6 months. Consent of parent or guardian if < 18 years of age. Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment). NOTE: Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Abnormal baseline chest x-ray. New pulmonary or cardiac symptoms. Psychological or emotional problems sufficient to prevent compliance with study medication. Concurrent Medication: Excluded: Systemic chemotherapy for malignancy. Acute or induction therapy for opportunistic infection. Antiretroviral drugs other than study drugs. Biological response modifiers. Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin. Patients with the following prior conditions are excluded: History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. Evidence of active pulmonary disease within 6 months prior to study entry. History of grade 3 or worse peripheral neuropathy. History of acute or chronic pancreatitis. Prior Medication: Excluded: Prior nevirapine. Excluded within 7 days prior to study entry: Acute therapy for opportunistic infection (maintenance therapy is permitted). Acute systemic therapy for a nonopportunistic infection or other medical condition. Antiretroviral drugs other than AZT, ddI, or ddC. Biological response modifiers. d4T therapy. Nucleosides other than those used in the study. Antibiotics containing clavulanate potassium. Prior Treatment: Excluded: More than 4 units of blood in a 30-day period. Active alcohol or drug abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry WK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kahn JO
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Balfour HH
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Children's Hosp of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Univ of Southern California / LA County USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Huntington Memorial Hosp / Children's Hosp of Los Angeles
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Stanford at Kaiser / Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
San Mateo AIDS Program / Stanford Univ
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Stanford Univ Med Ctr
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Olive View Med Ctr
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Denver Dept of Health and Hosps
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Mountain States Reg Hemo Ctr / Univ of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Rose Med Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Yale Univ / New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
065102483
Country
United States
Facility Name
HIV Ctr - District of Columbia Gen Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200072197
Country
United States
Facility Name
Whitman - Walker Clinic / Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200072197
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington Univ / Hershey Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Howard Univ
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Louis A Weiss Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Methodist Hosp of Indiana / Life Care Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Louisville / East Tennesee Comprehensive Hem Ctr
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Harvard (Massachusetts Gen Hosp)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess - West Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Hennepin County Med Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St Paul Ramsey Med Ctr
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
St Louis Regional Hosp / St Louis Regional Med Ctr
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Univ of Nebraska Med Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985130
Country
United States
Facility Name
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Robert Wood Johnson Med School / Hershey Med Ctr
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Adirondack Med Ctr at Saranac Lake
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
Albany Med College / Division of HIV Medicine A158
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
Mid - Hudson Care Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Comprehensive Health Care Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Family Health Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Samaritan Village Inc / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Jack Weiler Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Montefiore Med Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Central Bronx Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Bronx Veterans Administration / Mount Sinai Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112032098
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
North Shore Univ Hosp
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Saint Clare's Hosp and Health Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
100323784
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY / State Univ of New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Moses H Cone Memorial Hosp
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Univ of Kentucky Lexington
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Med Ctr
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
441091998
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
Med College of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43699
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Saint Michael's Med Ctr / Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Girard Med Ctr
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191046073
Country
United States
Facility Name
Univ of Pennsylvania at Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191075098
Country
United States
Facility Name
Med Univ of South Carolina / UNC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Meharry Med College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Univ of Texas Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550435
Country
United States
Facility Name
Univ Texas Health Science Ctr / Univ Texas Med School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
981224304
Country
United States
Facility Name
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Great Lakes Hemophilia Foundation
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
532130127
Country
United States
Facility Name
Univ of Puerto Rico
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9833742
Citation
Henry K, Erice A, Tierney C, Balfour HH Jr, Fischl MA, Kmack A, Liou SH, Kenton A, Hirsch MS, Phair J, Martinez A, Kahn JO. A randomized, controlled, double-blind study comparing the survival benefit of four different reverse transcriptase inhibitor therapies (three-drug, two-drug, and alternating drug) for the treatment of advanced AIDS. AIDS Clinical Trial Group 193A Study Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Dec 1;19(4):339-49. doi: 10.1097/00042560-199812010-00004.
Results Reference
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Citation
Price RW, Yiannoutsos C, Zaborski L, Kmack A, Henry K, Tierney C, Clifford D. Neurological substudies of ACTG protocol 193A: quantitative neurological performance measures and treatment outcomes. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:176 (abstract no 516)
Results Reference
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Citation
Robinson P, Cotton D, Curry R, Henry K, Hall D, Myers M. Analysis of nevirapine (NVP) effect on clinical endpoints (CEs) of HIV progression or death in ACTG trial 193A. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:210 (abstract no 700)
Results Reference
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Citation
Henry K, Tierney C, Kahn J, Balfour H, Jiang Q, Kmack A, Fischl M. A randomized, double-blind, placebo-controlled study comparing combination nucleoside and triple therapy for the treatment of advanced HIV disease (CD4 less than or equal to 50/mm(3)). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:207 (abstract no LB6)
Results Reference
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Citation
Coplan P, Nikas A, Saah A, Nessly M, Doll L, Leavitt R, Benson J, Guess H. No association observed between indinavir therapy for HIV/AIDS and myocardial infarction in 4 clinical trials with 2,825 subjects. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:191 (abstract no 658)
Results Reference
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Citation
Erice A, Tierney C, Balfour HH Jr, Liou S, Kahn JO, Henry WK. Virologlc effect of therapy with reverse transcriptase inhibitors (RTIs) in patients with AIDS and less than 50 CD4+ T cells per mm(3): a substudy of ACTG 193a. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:204 (abstract no 662)
Results Reference
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PubMed Identifier
10509569
Citation
Price RW, Yiannoutsos CT, Clifford DB, Zaborski L, Tselis A, Sidtis JJ, Cohen B, Hall CD, Erice A, Henry K. Neurological outcomes in late HIV infection: adverse impact of neurological impairment on survival and protective effect of antiviral therapy. AIDS Clinical Trial Group and Neurological AIDS Research Consortium study team. AIDS. 1999 Sep 10;13(13):1677-85. doi: 10.1097/00002030-199909100-00011.
Results Reference
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Learn more about this trial

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

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