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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001091

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

200

Expected to finish

2000-10-01

Last updated by the study team

2021-11-04

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, 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
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Children's Hosp of Oakland — Oakland, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Connecticut Children's Med Ctr - Pediatric — Hartford, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Washington Hosp Ctr — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• Univ of Florida Gainesville — Gainesville, Florida, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Palm Beach County Health Dept — Riviera Beach, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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