Home
Clinical Trials
NCT00000814

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

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1998-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Nevirapine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nevirapine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Burchett S

Role: STUDY_CHAIR

Luzuriaga K

Role: STUDY_CHAIR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Univ of Alabama at Birmingham Schl of Med / Pediatrics

Birmingham, Alabama, United States

Site Status

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States

Site Status

Long Beach Memorial (Pediatric)

Long Beach, California, United States

Site Status

Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Site Status

Cedars Sinai / UCLA Med Ctr

Los Angeles, California, United States

Site Status

UCLA Med Ctr / Pediatric

Los Angeles, California, United States

Site Status

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, United States

Site Status

Children's Hosp of Oakland

Oakland, California, United States

Site Status

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, United States

Site Status

Children's Hosp of Denver

Denver, Colorado, United States

Site Status

Univ of Connecticut / Farmington

Farmington, Connecticut, United States

Site Status

Yale Univ Med School

New Haven, Connecticut, United States

Site Status

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Children's Hosp of Washington DC

Washington D.C., District of Columbia, United States

Site Status

Howard Univ Hosp

Washington D.C., District of Columbia, United States

Site Status

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States

Site Status

Univ of Miami (Pediatric)

Miami, Florida, United States

Site Status

Emory Univ Hosp / Pediatrics

Atlanta, Georgia, United States

Site Status

Cook County Hosp

Chicago, Illinois, United States

Site Status

Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, United States

Site Status

Chicago Children's Memorial Hosp

Chicago, Illinois, United States

Site Status

Univ of Chicago Children's Hosp

Chicago, Illinois, United States

Site Status

Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, United States

Site Status

Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, United States

Site Status

Children's Hosp of Boston

Boston, Massachusetts, United States

Site Status

Baystate Med Ctr of Springfield

Springfield, Massachusetts, United States

Site Status

Univ of Massachusetts Med School

Worcester, Massachusetts, United States

Site Status

Children's Hosp of Michigan

Detroit, Michigan, United States

Site Status

UMDNJ - Robert Wood Johnson Med School / Pediatrics

New Brunswick, New Jersey, United States

Site Status

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

Newark, New Jersey, United States

Site Status

Children's Hosp at Albany Med Ctr

Albany, New York, United States

Site Status

King's County Hosp Ctr / Pediatrics

Brooklyn, New York, United States

Site Status

SUNY - Brooklyn

Brooklyn, New York, United States

Site Status

North Shore Univ Hosp

Great Neck, New York, United States

Site Status