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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 24, 2004
Last updated: February 24, 2006
Last verified: February 2006

August 24, 2004
February 24, 2006
April 2004
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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
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Complete list of historical versions of study NCT00090077 on Archive Site
Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments
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Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
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
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Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: GW695634
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: GSK Clinical Trial, MD GlaxoSmithKline
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP