A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment.

Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Didanosine; Lamivudine; Nelfinavir; Nevirapine; Ritonavir; Stavudine; Zalcitabine; Zidovudine

Criteria

Inclusion Criteria

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

• Is HIV-positive.

• Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18).

• Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy.

• Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy.

• Is able to receive at least one of the following: RTV, NVP, or NFV.

Exclusion Criteria

Your child will not be eligible for this study if he or she:

• Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry.

• Has a history of pancreatitis or peripheral neuropathy.

• Has cancer requiring chemotherapy.

• Is allergic to the study medications.

• Is taking certain medications.

• Is pregnant.