Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children.

T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Enfuvirtide

Criteria

Inclusion Criteria

Children may be eligible for this study if they:

• Are 3 to 12 years old (consent of parent or guardian required).

• Are HIV-positive.

• Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)

• Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.

• Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)

• Have never taken at least 1 NRTI.

Exclusion Criteria

Children will not be eligible for this study if they:

• Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.

• Are receiving chemotherapy for cancer.

• Have certain serious diseases (other than HIV) or conditions.

• Have received or are currently receiving certain medications.

• Are pregnant.