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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. \[AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for ...

Gender

ALL

Eligibility 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.

Trial Officials