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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00001091

Public ClinicalTrials.gov record NCT00001091. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV-Infected Children. PRAM-2: A Phase I/II Randomized, Multicenter Protocol Comparing Four Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs and an NNRTI

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00001091
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
200 participants

Conditions and interventions

Eligibility (public fields only)

Age range
4 Months to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Sep 30, 2000
Last update posted
Nov 3, 2021

Ends 2000

United States locations

U.S. sites
53
U.S. states
18
U.S. cities
35
Facility City State ZIP Site status
Univ of Alabama at Birmingham - Pediatric Birmingham Alabama 35233
UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California 920930672
Long Beach Memorial (Pediatric) Long Beach California 90801
Children's Hosp of Los Angeles/UCLA Med Ctr Los Angeles California 900276016
Los Angeles County - USC Med Ctr Los Angeles California 90033
UCLA Med Ctr / Pediatric Los Angeles California 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine Los Angeles California 905022004
Children's Hosp of Oakland Oakland California 946091809
UCSF / Moffitt Hosp - Pediatric San Francisco California 941430105
Connecticut Children's Med Ctr - Pediatric Hartford Connecticut 06106
Yale Univ Med School New Haven Connecticut 06504
Children's Hosp of Washington DC Washington D.C. District of Columbia 200102916
Washington Hosp Ctr Washington D.C. District of Columbia 200102931
Howard Univ Hosp Washington D.C. District of Columbia 20060
North Broward Hosp District Fort Lauderdale Florida 33311
Univ of Florida Gainesville Gainesville Florida 32610
Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida 32209
Palm Beach County Health Dept Riviera Beach Florida 33404
Emory Univ Hosp / Pediatrics Atlanta Georgia 30306
Med College of Georgia Augusta Georgia 30912
Cook County Hosp Chicago Illinois 60612
Univ of Illinois College of Medicine / Pediatrics Chicago Illinois 60612
Chicago Children's Memorial Hosp Chicago Illinois 606143394
Univ of Chicago Children's Hosp Chicago Illinois 606371470
Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana 701122699
Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland 21201
Johns Hopkins Hosp - Pediatric Baltimore Maryland 212874933
Baystate Med Ctr of Springfield Springfield Massachusetts 01199
Univ of Massachusetts Med School Worcester Massachusetts 016550001
Univ of Mississippi Med Ctr Jackson Mississippi 39213
UMDNJ - Robert Wood Johnson Med School / Pediatrics New Brunswick New Jersey 089030019
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark New Jersey 07103
King's County Hosp Ctr / Pediatrics Brooklyn New York 11203
SUNY - Brooklyn Brooklyn New York 11203
North Shore Univ Hosp Great Neck New York 11021
Schneider Children's Hosp New Hyde Park New York 11040
Bellevue Hosp / New York Univ Med Ctr New York New York 10016
Cornell Univ Med College New York New York 10021
Metropolitan Hosp Ctr New York New York 10029
Columbia Presbyterian Med Ctr New York New York 10032
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr New York New York 10032
Harlem Hosp Ctr New York New York 10037
Univ of Rochester Med Ctr Rochester New York 146420001
State Univ of New York at Stony Brook Stony Brook New York 117948111
Bronx Lebanon Hosp Ctr The Bronx New York 10457
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr The Bronx New York 10461
Bronx Municipal Hosp Ctr/Jacobi Med Ctr The Bronx New York 10461
Children's Hosp of Philadelphia Philadelphia Pennsylvania 191044318
Saint Christopher's Hosp for Children Philadelphia Pennsylvania 191341095
Med Univ of South Carolina Charleston South Carolina 294253312
Vanderbilt Univ Med Ctr Nashville Tennessee 372322581
Children's Hosp of the King's Daughters Norfolk Virginia 23507
Children's Hospital & Medical Center / Seattle ACTU Seattle Washington 981050371

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00001091, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00001091 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →