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NCT00001091

Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

Last Updated: 2021-11-04

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

200 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2000-10-31

Brief Summary

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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

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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. \[AS PER AMENDMENT 6/11/99: The study has been extended for an additional 48 weeks (96 weeks total) to permit long-term follow-up of clinically stable, HIV-infected children.\]

Conditions

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HIV Infections

Keywords

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Drug Therapy, Combination Nevirapine Stavudine HIV Protease Inhibitors Ritonavir Lamivudine Nelfinavir Reverse Transcriptase Inhibitors

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

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have received the same continuous anti-HIV treatment for the past 16 weeks (missing no more than 6 weeks of treatment total during those 16 weeks).
* Are between 4 months and 17 years old (consent of parent or guardian required).

Exclusion Criteria

Patients will not be eligible if they:

* Have certain serious conditions such as cancer, an opportunistic (AIDS-related) infection, or other serious infection.
* Have ever taken any of the study drugs or any protease inhibitor.
* Are currently taking any anti-HIV drugs.
* Have taken an investigational drug within 14 days of entry into the study. (Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection studies is allowed.)
* Are taking certain other drugs.
* Are pregnant.

Minimum Eligible Age

4 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Wiznia

Role: STUDY_CHAIR

George Johnson

Role: STUDY_CHAIR

Paul Krogstad

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham - Pediatric

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

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Children's Hosp of Los Angeles/UCLA Med Ctr

Los Angeles, California, United States

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

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UCLA Med Ctr / Pediatric

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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Connecticut Children's Med Ctr - Pediatric

Hartford, Connecticut, United States

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Yale Univ Med School

New Haven, Connecticut, United States

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Children's Hosp of Washington DC

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

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Washington Hosp Ctr

Washington D.C., District of Columbia, 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 Gainesville

Gainesville, Florida, United States

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Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States

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Palm Beach County Health Dept

Riviera Beach, 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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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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Univ of Chicago Children's 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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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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Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

Newark, New Jersey, United States

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King's County Hosp Ctr / Pediatrics

Brooklyn, 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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