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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Amprenavir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Children's Diagnostic Treatment Ctr

Fort Lauderdale, Florida, United States

Site Status

Saint Jude Children's Hosp / Dept of Infect Diseases

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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PROA3004

Identifier Type: -

Identifier Source: secondary_id

264C