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

This study has been completed.

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002193

Purpose

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).

Condition	Intervention	Phase
HIV Infections	Drug: Amprenavir	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: VX 478

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety Study
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

210

Detailed 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.

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002193

Locations

United States, Florida
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, United States, 33301
United States, Tennessee
Saint Jude Children's Hosp / Dept of Infect Diseases
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

Glaxo Wellcome

More Information

Study ID Numbers:	264C, PROA3004
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002193
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral

VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Study placed in the following topic categories:

Virus Diseases
Amprenavir
Sexually Transmitted Diseases, Viral
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Anti-Bacterial Agents
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on January 14, 2009