Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults

February 24, 2006 updated by: GlaxoSmithKline

A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.

To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Clinical Trials Call Center
    • California
      • Fountain Valley, California, United States, 92708
        • GSK Clinical Trials Call Center
      • San Francisco, California, United States, 94115
        • GSK Clinical Trials Call Center
      • West Hollywood, California, United States, 90069
        • GSK Clinical Trials Call Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • GSK Clinical Trials Call Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Clinical Trials Call Center
      • Miami, Florida, United States, 33136
        • GSK Clinical Trials Call Center
      • Miami Beach, Florida, United States, 33140
        • GSK Clinical Trials Call Center
      • Orlando, Florida, United States, 32804
        • GSK Clinical Trials Call Center
      • Vero Beach, Florida, United States, 32960
        • GSK Clinical Trials Call Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • GSK Clinical Trials Call Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Clinical Trials Call Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • GSK Clinical Trials Call Center
    • New York
      • New York, New York, United States, 10008
        • GSK Clinical Trials Call Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Clinical Trials Call Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Clinical Trials Call Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • GSK Clinical Trials Call Center
    • Washington
      • Seattle, Washington, United States, 98104
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • CD4 cell count greater than or equal to 200 cells/mm3.
  • HIV-1 RNA >2000 copies/mL.
  • Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
  • Normal resting 12-lead electrocardiogram.

Exclusion criteria:

  • Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.
  • Chronic diarrhea (>3 loose stools/day).
  • An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
  • Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
  • Any acute laboratory abnormality.
  • Positive for HCV antibody or HepBsAG.
  • Active infections requiring therapy in the previous 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7

Secondary Outcome Measures

Outcome Measure
Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trial, MD, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Registration Dates

First Submitted

August 24, 2004

First Submitted That Met QC Criteria

August 25, 2004

First Posted (Estimate)

August 26, 2004

Study Record Updates

Last Update Posted (Estimate)

February 27, 2006

Last Update Submitted That Met QC Criteria

February 24, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN210005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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