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A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nevirapine
Zidovudine
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 Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Nevirapine

Eligibility Criteria

6 Months - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Erythropoietin. Concurrent Treatment: Allowed: Transfusion. Patients must have: Progressive HIV disease. At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active malignancy requiring chemotherapy. Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study. Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study. Concurrent Medication: Excluded (unless exemption made by study chair): Oral anticoagulants (warfarin, dicumarol). Oral contraceptives. Digitalis glycosides. Phenytoin. Theophylline. Patients with the following prior conditions are excluded: History of clinical pancreatitis. History of grade 2 or worse peripheral neuropathy. Prior Treatment: Excluded: Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.

Sites / Locations

  • Univ of Alabama at Birmingham Schl of Med / Pediatrics
  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • Long Beach Memorial (Pediatric)
  • Los Angeles County - USC Med Ctr
  • Cedars Sinai / UCLA Med Ctr
  • UCLA Med Ctr / Pediatric
  • Harbor - UCLA Med Ctr / UCLA School of Medicine
  • Children's Hosp of Oakland
  • UCSF / Moffitt Hosp - Pediatric
  • Children's Hosp of Denver
  • Univ of Connecticut / Farmington
  • Yale Univ Med School
  • Georgetown Univ Med Ctr
  • Children's Hosp of Washington DC
  • Howard Univ Hosp
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami (Pediatric)
  • Emory Univ Hosp / Pediatrics
  • Cook County Hosp
  • Univ of Illinois College of Medicine / Pediatrics
  • Chicago Children's Memorial Hosp
  • Univ of Chicago Children's Hosp
  • Tulane Univ / Charity Hosp of New Orleans
  • Univ of Maryland at Baltimore / Univ Med Ctr
  • Johns Hopkins Hosp - Pediatric
  • Children's Hosp of Boston
  • Baystate Med Ctr of Springfield
  • Univ of Massachusetts Med School
  • Children's Hosp of Michigan
  • UMDNJ - Robert Wood Johnson Med School / Pediatrics
  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
  • Children's Hosp at Albany Med Ctr
  • Bronx Lebanon Hosp Ctr
  • Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
  • King's County Hosp Ctr / Pediatrics
  • SUNY - Brooklyn
  • North Shore Univ Hosp
  • Schneider Children's Hosp
  • Beth Israel Med Ctr / Pediatrics
  • Bellevue Hosp / New York Univ Med Ctr
  • Cornell Univ Med College
  • Metropolitan Hosp Ctr
  • Mount Sinai Med Ctr / Hemophilia Treatment Ctr
  • Mount Sinai Med Ctr / Pediatrics
  • Columbia Presbyterian Med Ctr
  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
  • Harlem Hosp Ctr
  • Univ of Rochester Medical Center
  • State Univ of New York at Stony Brook
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • Westchester Hosp
  • Duke Univ Med Ctr
  • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
  • Columbus Children's Hosp
  • West Central Ohio Hemophilia Ctr / Children's Med Ctr
  • Milton S Hershey Med Ctr
  • Univ of Pittsburgh Med School / Hershey Med Ctr
  • Children's Hosp of Philadelphia
  • Saint Christopher's Hosp for Children
  • Rhode Island Hosp / Brown Univ
  • Med Univ of South Carolina
  • Children's Med Ctr of Dallas
  • Texas Children's Hosp / Baylor Univ
  • Children's Hosp of the King's Daughters
  • Children's Hospital & Medical Center / Seattle ACTU
  • Ramon Ruiz Arnau Univ Hosp / Pediatrics
  • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • San Juan City Hosp

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)
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1. Study Identification

Unique Protocol Identification Number
NCT00000814
Brief Title
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
Official Title
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
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
November 1998 (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 compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
Detailed Description
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance. In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks. AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
390 (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)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Erythropoietin. Concurrent Treatment: Allowed: Transfusion. Patients must have: Progressive HIV disease. At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active malignancy requiring chemotherapy. Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study. Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study. Concurrent Medication: Excluded (unless exemption made by study chair): Oral anticoagulants (warfarin, dicumarol). Oral contraceptives. Digitalis glycosides. Phenytoin. Theophylline. Patients with the following prior conditions are excluded: History of clinical pancreatitis. History of grade 2 or worse peripheral neuropathy. Prior Treatment: Excluded: Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burchett S
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luzuriaga K
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham Schl of Med / Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Long Beach Memorial (Pediatric)
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900481804
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
Children's Hosp of Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
946091809
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Children's Hosp of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
802181088
Country
United States
Facility Name
Univ of Connecticut / Farmington
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale Univ Med School
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200072197
Country
United States
Facility Name
Children's Hosp of Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102916
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
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 Hosp / Pediatrics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Illinois College of Medicine / Pediatrics
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
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Univ of Maryland at Baltimore / Univ Med Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
Children's Hosp of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Med School / Pediatrics
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Children's Hosp at Albany Med Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
King's County Hosp Ctr / Pediatrics
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
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
Schneider Children's Hosp
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Med Ctr / Pediatrics
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
Cornell Univ Med College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Metropolitan Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
SUNY Health Sciences Ctr at Syracuse / Pediatrics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Westchester Hosp
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
West Central Ohio Hemophilia Ctr / Children's Med Ctr
City
Dayton
State/Province
Ohio
ZIP/Postal Code
454041815
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Univ of Pittsburgh Med School / Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Saint Christopher's Hosp for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191341095
Country
United States
Facility Name
Rhode Island Hosp / Brown Univ
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
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
Children's Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hosp / Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hosp of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Children's Hospital & Medical Center / Seattle ACTU
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
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 / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Results Reference
background
Citation
Burchett SK, Carey V, Yong F, Sullivan J, Sulzbacher S, Civitello L, Culnane M, Mofenson L, Siminski S, Robinson P, Luzuriaga K. Virologic activity of didanosine (ddI), zidovudine (ZDV) and nevirapine (NVP) combinations in pediatric subjects with advanced HIV disease (ACTG 245). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:130 (abstract no 271)
Results Reference
background
PubMed Identifier
21037891
Citation
Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
Results Reference
background
Citation
Burchett S, Sullivan J, Luzuriaga K, Carey V, Yong F, Culnane M, Mofenson L, Robinson P. Combinations of didanosine (DDI), zidovudine (ZDV) and nevirapine (NVP) can reduce CSF HIV-1 viral load in pediatric patients with advanced HIV disease. Int Conf AIDS. 1998;12:62 (abstract no 12253)
Results Reference
background

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A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

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