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NCT00000902

A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Last Updated: 2021-10-29

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-04-30

Brief Summary

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The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment.

Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.

Detailed Description

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The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load.

In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV). Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP, NFV, or RTV.

Prior to randomization to a NFV- or RTV-containing regimen, patients are stratified by HIV RNA (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.

Conditions

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HIV Infections

Keywords

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Zalcitabine Didanosine Drug Therapy, Combination Zidovudine Nevirapine Stavudine Ritonavir Lamivudine RNA, Viral Anti-HIV Agents Nelfinavir

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ritonavir

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Nevirapine

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Zalcitabine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Your child may be eligible for this study if he or she:

* Is HIV-positive.
* Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18).
* Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy.
* Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy.
* Is able to receive at least one of the following: RTV, NVP, or NFV.

Exclusion Criteria

Your child will not be eligible for this study if he or she:

* Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry.
* Has a history of pancreatitis or peripheral neuropathy.
* Has cancer requiring chemotherapy.
* Is allergic to the study medications.
* Is taking certain medications.
* Is pregnant.

Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Burchett

Role: STUDY_CHAIR

Andrea Kovacs

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham - Pediatric

Birmingham, Alabama, United States

Site Status

Univ of South Alabama

Mobile, Alabama, United States

Site Status

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States

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Long Beach Memorial (Pediatric)

Long Beach, California, United States

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

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Cedars Sinai / UCLA Med Ctr

Los Angeles, California, United States

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Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, United States

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Children's Hosp of Oakland

Oakland, California, United States

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UCSF / Moffitt Hosp - Pediatric

San Francisco, California, United States

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Children's Hosp of Denver

Denver, Colorado, United States

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Connecticut Children's Med Ctr

Farmington, Connecticut, United States

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Yale Univ Med School

New Haven, Connecticut, United States

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Howard Univ Hosp

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

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North Broward Hosp District

Fort Lauderdale, Florida, United States

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Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States

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Univ of Miami (Pediatric)

Miami, Florida, United States

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Emory Univ Hosp / Pediatrics

Atlanta, Georgia, United States

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Med College of Georgia

Augusta, Georgia, United States

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The Med Ctr Inc

Columbus, Georgia, United States

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Cook County Hosp

Chicago, Illinois, United States

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Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, United States

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Chicago Children's Memorial Hosp

Chicago, Illinois, United States

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Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, United States

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Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, United States

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Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, United States

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Children's Hosp of Boston

Boston, Massachusetts, United States

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Boston City Hosp / Pediatrics

Boston, Massachusetts, United States

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Baystate Med Ctr of Springfield

Springfield, Massachusetts, United States

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Univ of Massachusetts Med School

Worcester, Massachusetts, United States

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Univ of Mississippi Med Ctr

Jackson, Mississippi, United States

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UMDNJ - Robert Wood Johnson Med School / Pediatrics

New Brunswick, New Jersey, United States

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Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, United States

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

Newark, New Jersey, United States

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Children's Hosp at Albany Med Ctr

Albany, New York, United States

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SUNY - Brooklyn

Brooklyn, New York, United States

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North Shore Univ Hosp

Great Neck, New York, United States

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