Clinical trial NCT00090077: Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: GW695634G
GW695634X
GW678248X
pharmacokinetics
NNRTI
HIV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
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 outcomes:
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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Fountain Valley
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: San Francisco
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: West Hollywood
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Washington
country: United States
facility: GSK Clinical Trials Call Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Miami Beach
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Miami
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Orlando
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Vero Beach
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Boston
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Las Vegas
country: United States
facility: GSK Clinical Trials Call Center
state: Nevada
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Charlotte
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Clinical Trials Call Center
state: Oklahoma
city: Fort Worth
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Seattle
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trial, MD
role: STUDY_DIRECTOR
References: