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

• Status: Completed
• Trial end date: 2000-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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: HIV Protease Inhibitors; Lamivudine; Nelfinavir; Nevirapine; Protease Inhibitors; Ritonavir; Stavudine

Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.