A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
- Conditions
- HIV Infections
- Registration Number
- NCT00000902
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Connecticut Children's Med Ctr
🇺🇸Farmington, Connecticut, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Univ of South Alabama
🇺🇸Mobile, Alabama, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
The Med Ctr Inc
🇺🇸Columbus, Georgia, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
🇺🇸New Brunswick, New Jersey, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Med College of Virginia
🇺🇸Richmond, Virginia, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Saint Christopher's Hosp for Children
🇺🇸Philadelphia, Pennsylvania, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico