A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients

GlaxoSmithKline100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

HIV Infections

Interventions

GW810781DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

GSK Clinical Trials Call Center

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Plasma HIV-1 RNA change from baseline by Day 11.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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