CClinicalTrials.gg
CompletedNCT00090077Updated Feb 27, 2006

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

A Phase 1 interventional study of GW695634 in HIV Infections, sponsored by GlaxoSmithKline. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-02-27.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • HIV Infections

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Keywords

  • GW695634G
  • GW695634X
  • GW678248X
  • pharmacokinetics
  • NNRTI
  • HIV
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 50 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
50 participants

Interventions

  • DrugGW695634
06

What researchers measure

Primary outcomes

  1. 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 outcomes

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

07

Study locations

18 sites
  • GSK Clinical Trials Call Center
    Phoenix, Arizona 85006, United States
  • GSK Clinical Trials Call Center
    Fountain Valley, California 92708, United States
  • GSK Clinical Trials Call Center
    San Francisco, California 94115, United States
  • GSK Clinical Trials Call Center
    West Hollywood, California 90069, United States
  • GSK Clinical Trials Call Center
    Washington, District of Columbia 20007, United States
  • GSK Clinical Trials Call Center
    Fort Lauderdale, Florida 33308, United States
  • GSK Clinical Trials Call Center
    Miami Beach, Florida 33140, United States
  • GSK Clinical Trials Call Center
    Miami, Florida 33136, United States
  • GSK Clinical Trials Call Center
    Orlando, Florida 32804, United States
  • GSK Clinical Trials Call Center
    Vero Beach, Florida 32960, United States
  • GSK Clinical Trials Call Center
    Atlanta, Georgia 30308, United States
  • GSK Clinical Trials Call Center
    Boston, Massachusetts 02215, United States
  • GSK Clinical Trials Call Center
    Las Vegas, Nevada 89102, United States
  • GSK Clinical Trials Call Center
    New York, New York 10008, United States
  • GSK Clinical Trials Call Center
    Charlotte, North Carolina 28209, United States
  • GSK Clinical Trials Call Center
    Oklahoma City, Oklahoma 73104, United States
  • GSK Clinical Trials Call Center
    Fort Worth, Texas 76104, United States
  • GSK Clinical Trials Call Center
    Seattle, Washington 98104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00090077
Lead sponsor
GlaxoSmithKline
First posted
Aug 26, 2004
Start date
Apr 2004
Last update
Feb 27, 2006

Study contacts

GSK Clinical Trial, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.

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