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

NCT00000865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-10-28

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Abacavir sulfate

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Zidovudine

DRUG

Didanosine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kline M

  • Van Dyke R

  • Yogev R

  • Shenep J

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
3 Months
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1998-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000865 on ClinicalTrials.gov