Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
- Conditions
- HIV Infections
- Registration Number
- NCT00001091
- Brief Summary
The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations.
Decreasing HIV levels in infected patients can slow down disease progression. Further study is needed to find out which drug combinations are most effective in doing this.
- Detailed Description
For PRAM 2: Evidence suggests that as a consequence of antiviral therapy, decreases in plasma HIV-1 RNA are strongly associated with a delay in clinical progression. Therefore, the drug regimens proposed in this study are designed to result in a much larger sustained drop in plasma HIV-1 RNA and greater clinical benefit. Further intent of this study is to evaluate the virologic and therapeutic potential of novel combinations of antiretrovirals and to better define the pharmacokinetics and drug-drug interactions of therapies included in this regimen.
The Master PRAM schema is designed to allow new therapeutic arms to be studied as "rolling screens" through multiple generations of PRAMs. There is a common, "linking" regimen between any 2 sequential PRAM generations that will permit an indirect comparison of included therapies. (NOTE: Due to significant changes in study design between PRAM 1 and PRAM 2, there is no "linking" arm between them. The linkage will be reinstated from PRAM 2 and subsequent PRAM generations.) The therapeutic potential of the treatment arms is assessed by their ability to decrease HIV copy numbers as defined by plasma HIV-1 RNA copy number. Once accrual to a PRAM is complete, a new treatment comparison will open for accrual.
For PRAM 2: This study will compare the following 4 treatment arms:
Arm A - stavudine (d4T)/nevirapine/ritonavir Arm B - d4T/lamivudine (3TC)/nelfinavir Arm C - d4T/nevirapine/nelfinavir Arm D - d4T/3TC/nevirapine/nelfinavir. Prior to randomization to 1 of the PRAM 2 treatment arms, patients are stratified based on their CD4% (less than 25% and greater than or equal to 25%) and by age (less than 24 months and greater than or equal to 24 months). The first 35 subjects/treatment arm are evaluated with special immunologic studies including lymphoproliferative assays and extended panel immunophenotyping. There is an interim analysis after all patients have completed 12 weeks of treatment. Patients are treated for 48 weeks. \[AS PER AMENDMENT 6/11/99: The study has been extended for an additional 48 weeks (96 weeks total) to permit long-term follow-up of clinically stable, HIV-infected children.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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 (55)
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, 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
Saint Christopher's Hosp for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Palm Beach County Health Dept
🇺🇸Riviera Beach, Florida, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Washington Hosp Ctr
🇺🇸Washington, District of Columbia, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Connecticut Children's Med Ctr - Pediatric
🇺🇸Hartford, Connecticut, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Univ of Florida Gainesville
🇺🇸Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
King's County Hosp Ctr / Pediatrics
🇺🇸Brooklyn, New York, United States
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
🇺🇸New Brunswick, New Jersey, United States
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States