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NCT00090077 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00090077
Other study ID # NN210005
Secondary ID
Status Completed
Phase Phase 1
First received August 24, 2004
Last updated February 24, 2006
Start date April 2004

Study information
Verified date February 2006
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GW695634

Locations
Country Name City State
United States GSK Clinical Trials Call Center Atlanta Georgia
United States GSK Clinical Trials Call Center Boston Massachusetts
United States GSK Clinical Trials Call Center Charlotte North Carolina
United States GSK Clinical Trials Call Center Fort Lauderdale Florida
United States GSK Clinical Trials Call Center Fort Worth Texas
United States GSK Clinical Trials Call Center Fountain Valley California
United States GSK Clinical Trials Call Center Las Vegas Nevada
United States GSK Clinical Trials Call Center Miami Florida
United States GSK Clinical Trials Call Center Miami Beach Florida
United States GSK Clinical Trials Call Center New York New York
United States GSK Clinical Trials Call Center Oklahoma City Oklahoma
United States GSK Clinical Trials Call Center Orlando Florida
United States GSK Clinical Trials Call Center Phoenix Arizona
United States GSK Clinical Trials Call Center San Francisco California
United States GSK Clinical Trials Call Center Seattle Washington
United States GSK Clinical Trials Call Center Vero Beach Florida
United States GSK Clinical Trials Call Center Washington District of Columbia
United States GSK Clinical Trials Call Center West Hollywood California

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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