Overview

The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Status:
Completed

Trial end date:
1998-04-01

Target enrollment:

Participant gender:

Summary

To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials. On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.

Phase:

Phase 1

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Treatments:

Abacavir
Anti-Retroviral Agents
Didanosine
Lamivudine
Stavudine
Zidovudine