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

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

RAD-1: A Phase I/II Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

217

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, 35233
        • Univ of Alabama at Birmingham - Pediatric
      • Mobile, Alabama, United States, 36604
        • Univ of South Alabama
    • 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
      • 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, 060303805
        • Connecticut Children's Med Ctr
      • New Haven, Connecticut, United States, 06504
        • Yale Univ Med School
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard Univ Hosp
    • Florida
      • Fort Lauderdale, Florida, United States, 33311
        • North Broward Hosp District
      • 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
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
      • Columbus, Georgia, United States, 31901
        • The Med Ctr Inc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's Memorial 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
      • Boston, Massachusetts, United States, 02118
        • Boston City Hosp / Pediatrics
      • Springfield, Massachusetts, United States, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, United States, 016550001
        • Univ of Massachusetts Med School
    • Mississippi
      • Jackson, Mississippi, United States, 39213
        • Univ of Mississippi Med Ctr
    • New Jersey
      • New Brunswick, New Jersey, United States, 089030019
        • UMDNJ - Robert Wood Johnson Med School / Pediatrics
      • Newark, New Jersey, United States, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
      • 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
      • 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
      • Rochester, New York, United States, 146420001
        • Univ of Rochester Med Ctr
      • 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
    • 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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 191044318
        • Children's Hosp of Philadelphia
      • Philadelphia, Pennsylvania, United States, 191341095
        • Saint Christopher's Hosp for Children
    • South Carolina
      • Charleston, South Carolina, United States, 294253312
        • Med Univ of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 381052794
        • Saint Jude Children's Research Hosp of Memphis
      • Nashville, Tennessee, United States, 372322581
        • Vanderbilt Univ Med Ctr
    • 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
      • Richmond, Virginia, United States, 23219
        • Med College of Virginia

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 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Sandra Burchett
  • Study Chair: Andrea Kovacs

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

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)

April 1, 2002

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 29, 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 366
  • 11329 (Registry Identifier: DAIDS ES)

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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