Clinical trial NCT00046332: A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
Official title: A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Integrase inhibitors
Monotherapy
HIV-1 infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Shionogi
First posted: 2002-09-30
Enrollment: 100
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: This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.


Eligibility criteria: Inclusion Criteria:

* No prior HIV medications.
* HIV infection with viral load \>400-50,000 copies/mL.
* CD4 cell count \>50 cells/mm.

Exclusion Criteria:

* Patients requiring medications that cannot be interrupted for the duration of the study.
* Abnormal ECG or other chronic health conditions as noted on screening physical exam.
* Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this study.

Primary outcomes:
measure: Plasma HIV-1 RNA change from baseline by Day 11.
Secondary outcomes:
measure: HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Los Angeles
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: San Diego
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: Denver
country: United States
facility: GSK Clinical Trials Call Center
state: Colorado
city: Washington
country: United States
facility: GSK Clinical Trials Call Center
state: District of Columbia
city: Altamonte Springs
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Ft. Lauderdale
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: Tampa
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: Indianapolis
country: United States
facility: GSK Clinical Trials Call Center
state: Indiana
city: Minneapolis
country: United States
facility: GSK Clinical Trials Call Center
state: Minnesota
city: Bronx
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Chapel Hill
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Charlotte
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Durham
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Dallas
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Houston
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trial, MD,MPH
role: STUDY_DIRECTOR
References: