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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

390

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Ramon Ruiz Arnau Univ Hosp / Pediatrics
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham Schl of Med / Pediatrics
    • California
      • La Jolla, California, United States, 920930672
        • UCSD Med Ctr / Pediatrics / Clinical Sciences
      • Long Beach, California, United States, 90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, United States, 900481804
        • Cedars Sinai / UCLA Med Ctr
      • Los Angeles, California, United States, 905022004
        • Harbor - UCLA Med Ctr / UCLA School of Medicine
      • Los Angeles, California, United States, 900951752
        • UCLA Med Ctr / Pediatric
      • Oakland, California, United States, 946091809
        • Children's Hosp of Oakland
      • San Francisco, California, United States, 941430105
        • UCSF / Moffitt Hosp - Pediatric
    • Colorado
      • Denver, Colorado, United States, 802181088
        • Children's Hosp of Denver
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Univ of Connecticut / Farmington
      • New Haven, Connecticut, United States, 06504
        • Yale Univ Med School
    • District of Columbia
      • Washington, District of Columbia, United States, 200102916
        • Children's Hosp of Washington DC
      • Washington, District of Columbia, United States, 20060
        • Howard Univ Hosp
      • Washington, District of Columbia, United States, 200072197
        • Georgetown Univ Med Ctr
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, United States, 33161
        • Univ of Miami (Pediatric)
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory Univ Hosp / Pediatrics
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, United States, 606371470
        • Univ of Chicago Children's Hosp
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois College of Medicine / Pediatrics
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ / Charity Hosp of New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
      • Baltimore, Maryland, United States, 212874933
        • Johns Hopkins Hosp - Pediatric
    • Massachusetts
      • Boston, Massachusetts, United States, 021155724
        • Children's Hosp of Boston
      • Springfield, Massachusetts, United States, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, United States, 016550001
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hosp of Michigan
    • New Jersey
      • New Brunswick, New Jersey, United States, 089030019
        • UMDNJ - Robert Wood Johnson Med School / Pediatrics
      • Newark, New Jersey, United States, 07103
        • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
    • New York
      • Albany, New York, United States, 12208
        • Children's Hosp at Albany Med Ctr
      • Bronx, New York, United States, 10457
        • Bronx Lebanon Hosp Ctr
      • Bronx, New York, United States, 10461
        • Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
      • Brooklyn, New York, United States, 11203
        • King's County Hosp Ctr / Pediatrics
      • Brooklyn, New York, United States, 11203
        • SUNY - Brooklyn
      • Great Neck, New York, United States, 11021
        • North Shore Univ Hosp
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hosp
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10029
        • Metropolitan Hosp Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med College
      • New York, New York, United States, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10037
        • Harlem Hosp Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr / Pediatrics
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr / Pediatrics
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr / Hemophilia Treatment Ctr
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
      • Stony Brook, New York, United States, 117948111
        • State Univ of New York at Stony Brook
      • Syracuse, New York, United States, 13210
        • SUNY Health Sciences Ctr at Syracuse / Pediatrics
      • Valhalla, New York, United States, 10595
        • Westchester Hosp
    • North Carolina
      • Durham, North Carolina, United States, 277103499
        • Duke Univ Med Ctr
      • Durham, North Carolina, United States, 27710
        • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
    • Ohio
      • Columbus, Ohio, United States, 432052696
        • Columbus Children's Hosp
      • Dayton, Ohio, United States, 454041815
        • West Central Ohio Hemophilia Ctr / Children's Med Ctr
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 170330850
        • Milton S Hershey Med Ctr
      • Hershey, Pennsylvania, United States, 170330850
        • Univ of Pittsburgh Med School / Hershey Med Ctr
      • Philadelphia, Pennsylvania, United States, 191044318
        • Children's Hosp of Philadelphia
      • Philadelphia, Pennsylvania, United States, 191341095
        • Saint Christopher's Hosp for Children
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hosp / Brown Univ
    • South Carolina
      • Charleston, South Carolina, United States, 294253312
        • Med Univ of South Carolina
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Med Ctr of Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp / Baylor Univ
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hosp of the King's Daughters
    • Washington
      • Seattle, Washington, United States, 981050371
        • Children's Hospital & Medical Center / Seattle ACTU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Burchett S
  • Study Chair: Luzuriaga K

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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
  • 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)
  • 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

November 1, 1998

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 245
  • 11222 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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