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.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: VX 478

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00002193 History of Changes
Other Study ID Numbers:	264C, PROA3004
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Amprenavir
HIV Protease Inhibitors

Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on February 13, 2012