Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors

HIV Infections Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of 141W94 Plus Current Nucleoside Therapy Versus Current Nucleoside Therapy Alone in Protease-Naive, HIV-Infected Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002193
• Other study ID #: 264C
• Secondary ID: PROA3004
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).

Description:

In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children < 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria

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

• Is 6 months - 18 years of age.

• Is HIV-positive.

• Has a viral load (level of HIV in the body) greater than 10,000 copies/ml.

• Is able to take medications by mouth.

• Has consent of parent or legal guardian if under 18.

• Has a negative pregnancy test within 7 days of study entry.

• Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study.

Exclusion Criteria

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

• Has a serious illness, including any life-threatening infection or other chronic serious medical condition.

• Has an opportunistic (AIDS-related) infection or a serious bacterial infection.

• Is allergic to NRTIs.

• Is breast-feeding.

• Is unlikely to complete the study.

• Has received certain medications.

• Has received radiation therapy within the past 4 months, or will need to receive it during the study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Amprenavir

Locations

Country	Name	City	State
United States	Children's Diagnostic Treatment Ctr	Fort Lauderdale	Florida
United States	Saint Jude Children's Hosp / Dept of Infect Diseases	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,