A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs.

SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Nelfinavir; Ritonavir; Saquinavir

Criteria

Inclusion Criteria

Your child may be eligible for this study if he or she:

• Is HIV-positive.

• Is 3 to 16 years of age (consent of parent or guardian is required).

• Has an HIV level greater than 10,000 copies/ml.

• Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine.

• Is able to swallow capsules and tablets.

Exclusion Criteria

Your child will not be eligible if he or she:

• Has cancer requiring chemotherapy.

• Has an acute opportunistic (AIDS-related) infection requiring therapy.

• Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry.

• Has ever taken SQV or NFV.

• Is pregnant or breast-feeding.

• Is taking certain medications, including those that would interfere with the study drugs.