Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

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 an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.

Key facts

Study ID

NCT00000901

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Expected to finish

2000-10-01

Last updated by the study team

2021-10-28

Who can join

Age: 3 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Your child may be eligible for this study if he/she:
• Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits.
• Is HIV-positive.
• Is generally healthy.
• Is able to swallow medication in capsule form.
• Has never taken d4T or has never taken 3TC.
• Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study.

You may not qualify if…

• Your child will not be eligible for this study if he/she:
• Has a serious infection at the time of study entry.
• Has a history of severe diarrhea.
• Is unable to take any of the medications in this study for any reason.
• Has a history of certain serious illnesses.
• Has taken any protease inhibitors (PIs).
• Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry.
• Has taken certain medications.
• Is pregnant or breast-feeding.

Where it is running

• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Univ of Florida Gainesville — Gainesville, Florida, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• North Shore Univ Hosp — Great Neck, New York, United States
• Schneider Children's Hosp — New Hyde Park, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Incarnation Children's Ctr / Columbia Presbyterian Med Ctr — New York, New York, United States
• SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Children's Hosp of Philadelphia — Philadelphia, Pennsylvania, United States
• Med Univ of South Carolina — Charleston, South Carolina, United States
• Saint Jude Children's Research Hosp of Memphis — Memphis, Tennessee, United States
• Children's Hospital & Medical Center / Seattle ACTU — Seattle, Washington, United States
• San Juan City Hosp — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.