Back to resultsA Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Lamivudine
Stavudine
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis. Allowed: Topical or oral antifungal agents (other than oral ketoconazole). Approved agents for opportunistic infections. Antibiotics unless specifically excluded. Systemic corticosteroids for no more than 21 days. Vitamins. Recombinant erythropoietin. G-CSF. Regularly prescribed medications such as allergy medications, antidepressants, antipyretics, analgesics, oral contraceptives, megestrol, and testosterone. Concurrent Treatment: Allowed: Acupuncture. Visualization techniques. Patients must have: HIV infection. CD4 count <= 200 cells/mm3. At least 6 months total prior AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy requiring systemic therapy other than minimal Kaposi's sarcoma. Concurrent Medication: Excluded: Antiretrovirals other than study drugs. Rifabutin and rifampin. Investigational drugs other than indinavir sulfate. Systemic cytotoxic chemotherapy. Oral ketoconazole. Chronic systemic corticosteroids. Herbal therapies. Patients with the following prior conditions are excluded: Unexplained temperature > 38.5 C for any 7 days within 30 days prior to study entry. Chronic diarrhea persisting for 15 days within 30 days prior to study entry. History of acute or chronic pancreatitis. Acute hepatitis within 30 days prior to study entry. Grade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry. Dose-limiting intolerance to prior AZT at 600 mg/day. Prior Medication: Excluded: More than 1 week of prior 3TC. Any prior protease inhibitors. Rifampin or rifabutin within 14 days prior to study entry. Excluded within 30 days prior to study entry: Erythropoietin. G-CSF or GM-CSF. Non-nucleoside reverse transcriptase inhibitors. Interferons. Interleukins. HIV vaccines. Any experimental therapy.
Sites / Locations
- Univ of Alabama at Birmingham
- Children's Hosp of Los Angeles
- Univ of Southern California / LA County USC Med Ctr
- UCLA CARE Ctr
- 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
- San Mateo AIDS Program / Stanford Univ
- Stanford Univ Med Ctr
- Harbor UCLA Med Ctr
- Kaiser Permanente Franklin Med Ctr
- Mountain States Reg Hemo Ctr / Univ of Colorado
- Univ of Colorado Health Sciences Ctr
- George Washington Univ / Hershey Med Ctr
- Georgetown Univ Hosp
- Howard Univ
- Univ of Miami School of Medicine
- Univ of Miami (Pediatric)
- Emory Univ
- Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
- Queens Med Ctr
- Univ of Hawaii
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- Chicago Children's Memorial Hosp
- Louis A Weiss Memorial Hosp
- Illinois Masonic Med Ctr
- Indiana Univ Hosp
- Division of Inf Diseases/ Indiana Univ Hosp
- Methodist Hosp of Indiana / Life Care Clinic
- Univ of Iowa Hosp and Clinic
- Charity Hosp / Tulane Univ Med School
- Tulane Med Ctr Hosp
- Tulane Univ School of Medicine
- State of MD Div of Corrections / Johns Hopkins Univ Hosp
- Johns Hopkins Hosp
- 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
- Montefiore Med Ctr Adolescent AIDS Program
- Bronx Veterans Administration / Mount Sinai Hosp
- SUNY / Erie County Med Ctr at Buffalo
- North Shore Univ Hosp
- Beth Israel Med Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Kaplan Cancer Ctr / New York Univ Med Ctr
- Manhattan Veterans Administration / New York Univ Med Ctr
- Saint Clare's Hosp and Health Ctr
- Cornell Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
- Mount Sinai Med Ctr / Hemophilia Treatment Ctr
- Mount Sinai Med Ctr / Pediatrics
- Mount Sinai Med Ctr
- Harlem Hosp Ctr
- Univ of Rochester Medical Center
- SUNY / State Univ of New York
- Univ of North Carolina
- Carolinas Med Ctr
- Duke Univ Med Ctr
- Moses H Cone Memorial Hosp
- Central Prison/Women's Prison in Raleigh / NC
- Univ of Cincinnati
- Univ of Kentucky Lexington
- Case Western Reserve Univ
- Columbus Children's Hosp
- Ohio State Univ Hosp Clinic
- Milton S Hershey Med Ctr
- Thomas Jefferson Univ Hosp
- Med Univ of South Carolina
- Julio Arroyo
- Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
- Meharry Med College
- Vanderbilt Univ Med Ctr
- Univ of Texas Galveston
- Univ Texas Health Science Ctr / Univ Texas Med School
- Univ of Washington
- Great Lakes Hemophilia Foundation
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
- Univ of Puerto Rico
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000841
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00000841
Brief Title
A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
Official Title
A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience
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
June 1997 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients.
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
Detailed Description
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks. Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine ( d4T ) for AZT. Patients are followed at weeks 4, 8, 16, 24, 32, 40, and 48 and every 8 weeks thereafter up to week 96. [AS PER 02/25/97 AMENDMENT: Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy. An open label extension phase has been added for the period through 06/30/97. Patients who had been randomized to AZT/3TC are given the option of continuing on assigned ACTG 320 study drugs, crossing over to open-label indinavir, or permanently discontinuing all study therapies and going off study. Patients who were randomized to AZT/3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies. It is strongly suggested that patients who were on AZT/3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible.] [ AS PER 06/06/97 AMENDMENT: The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks (but not beyond 09/30/97). This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual (the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized).] [ AS PER 09/15/97 AMENDMENT: Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372.]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
1750 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Required:
PCP prophylaxis.
Allowed:
Topical or oral antifungal agents (other than oral ketoconazole).
Approved agents for opportunistic infections.
Antibiotics unless specifically excluded.
Systemic corticosteroids for no more than 21 days.
Vitamins.
Recombinant erythropoietin.
G-CSF.
Regularly prescribed medications such as allergy medications, antidepressants, antipyretics, analgesics, oral contraceptives, megestrol, and testosterone.
Concurrent Treatment:
Allowed:
Acupuncture.
Visualization techniques.
Patients must have:
HIV infection.
CD4 count <= 200 cells/mm3.
At least 6 months total prior AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Malignancy requiring systemic therapy other than minimal Kaposi's sarcoma.
Concurrent Medication:
Excluded:
Antiretrovirals other than study drugs.
Rifabutin and rifampin.
Investigational drugs other than indinavir sulfate.
Systemic cytotoxic chemotherapy.
Oral ketoconazole.
Chronic systemic corticosteroids.
Herbal therapies.
Patients with the following prior conditions are excluded:
Unexplained temperature > 38.5 C for any 7 days within 30 days prior to study entry.
Chronic diarrhea persisting for 15 days within 30 days prior to study entry.
History of acute or chronic pancreatitis.
Acute hepatitis within 30 days prior to study entry.
Grade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry.
Dose-limiting intolerance to prior AZT at 600 mg/day.
Prior Medication:
Excluded:
More than 1 week of prior 3TC.
Any prior protease inhibitors.
Rifampin or rifabutin within 14 days prior to study entry.
Excluded within 30 days prior to study entry:
Erythropoietin.
G-CSF or GM-CSF.
Non-nucleoside reverse transcriptase inhibitors.
Interferons.
Interleukins.
HIV vaccines.
Any experimental therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hammer SM
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Squires KE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fischl MA
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
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
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
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Kaiser Permanente Franklin Med Ctr
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
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
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
Georgetown Univ Hosp
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 Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
303652225
Country
United States
Facility Name
Queens Med Ctr
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
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
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Louis A Weiss Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Illinois Masonic Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606575147
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Division of Inf Diseases/ Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
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 Iowa Hosp and Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Charity Hosp / Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Med Ctr Hosp
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
State of MD Div of Corrections / Johns Hopkins Univ Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212052196
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
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
Montefiore Med Ctr Adolescent AIDS Program
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 / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
North Shore Univ Hosp
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
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
Kaplan Cancer Ctr / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Manhattan Veterans Administration / 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
St Vincent's Hosp / 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 / Pediatrics
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
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
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
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
Central Prison/Women's Prison in Raleigh / NC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
276260540
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
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
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
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
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
Vanderbilt Univ Med Ctr
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
Great Lakes Hemophilia Foundation
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
532130127
Country
United States
Facility Name
Ramon Ruiz Arnau Univ Hosp / Pediatrics
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Univ of Puerto Rico
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
Citation
Reiter G, Wojnarowski C. Low rate of nelfinavir discontinuation in a clinic population. Int Conf AIDS. 1998;12:1049 (abstract no 60273)
Results Reference
background
PubMed Identifier
11361796
Citation
ACTG 320 trial halted as three-drug arm proves superior. AIDS Patient Care STDS. 1997 Jun;11(3):194. No abstract available.
Results Reference
background
PubMed Identifier
11364769
Citation
Conference updates show promising drug data. AIDS Alert. 1997 Nov;12(11):125-6.
Results Reference
background
PubMed Identifier
11364527
Citation
Baker R. 3-drug therapy reduces deaths and new AIDS-related illnesses by 50%. BETA. 1997 Mar:3-4.
Results Reference
background
PubMed Identifier
11730396
Citation
Demeter LM, Hughes MD, Coombs RW, Jackson JB, Grimes JM, Bosch RJ, Fiscus SA, Spector SA, Squires KE, Fischl MA, Hammer SM. Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320. Ann Intern Med. 2001 Dec 4;135(11):954-64. doi: 10.7326/0003-4819-135-11-200112040-00007.
Results Reference
background
PubMed Identifier
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Learn more about this trial
A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
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