Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children

Completed · Phase 2/Phase 3

Conditions studied: HIV Infections

In brief

Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.

Key facts

Study ID

NCT00039741

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

266

Starts

2002-08-01

Expected to finish

2010-03-01

Last updated by the study team

2021-11-05

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Older than 30 days and younger than 18 years of age (may enroll up to the day before their 18th birthday)
• HIV infected
• Not previously on HAART or received anti-HIV drugs for less than 56 consecutive days after birth to prevent mother-to-infant HIV transmission. Participants who have previously received nevirapine for the prevention of mother-to-infant HIV transmission are not eligible for this study.
• Willing to use acceptable methods of contraception

You may not qualify if…

• Grade 3 or 4 clinical or laboratory toxicity. More information on this criterion can be found in the protocol.
• Active opportunistic infection or a serious bacterial infection at the time of study entry
• Pancreas, nervous system, blood, liver, or kidney problems that make it impossible to take study medications
• Taking any medication that cannot be combined with the study medications in first-line therapy
• Received therapy for cancer
• Pregnant or breastfeeding

Where it is running

• Usc La Nichd Crs — Alhambra, California, United States
• Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach, California, United States
• Children's Hospital of Los Angeles NICHD CRS — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• Connecticut Children's Med. Ctr. — Hartford, Connecticut, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy — Gainesville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• USF - Tampa NICHD CRS — Tampa, Florida, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Tulane Univ. New Orleans NICHD CRS — New Orleans, Louisiana, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Washington University Therapeutics (WT) CRS — St Louis, Missouri, United States
• UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases — New Brunswick, New Jersey, United States
• Rutgers - New Jersey Medical School CRS — Newark, New Jersey, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Columbia IMPAACT CRS — New York, New York, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• SUNY Stony Brook NICHD CRS — Stony Brook, New York, United States
• SUNY Upstate Med. Univ., Dept. of Peds. — Syracuse, New York, United States
• Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
• UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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