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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002193
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Amprenavir Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 210 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Amprenavir

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002193

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 Identifier: NCT00002193     History of Changes
Other Study ID Numbers: 264C
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents