A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

• Status: Completed
• Trial end date: 1998-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.

The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Didanosine; Nevirapine; Zidovudine

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Erythropoietin.

Concurrent Treatment:

Allowed:

• Transfusion.

Patients must have:

• Progressive HIV disease.

• At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Active malignancy requiring chemotherapy.

• Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.

• Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.

Concurrent Medication:

Excluded (unless exemption made by study chair):

• Oral anticoagulants (warfarin, dicumarol).

• Oral contraceptives.

• Digitalis glycosides.

• Phenytoin.

• Theophylline.

Patients with the following prior conditions are excluded:

• History of clinical pancreatitis.

• History of grade 2 or worse peripheral neuropathy.

Prior Treatment:

Excluded:

• Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.