Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults

A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00398125

Enrollment

Registered

2006-11-10

Start date

2006-11-30

Completion date

2007-04-30

Last updated

2012-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection, Infection, Human Immunodeficiency Virus

Keywords

GSK364735, HIV-1, integrase inhibitor

Brief summary

To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults

Interventions

DRUGGSK364735

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL. * Baseline CD4 cell count greater than 100. * Females must be of non-childbearing potential * Not have received antiretroviral therapy in the 12 weeks prior to first dose.

Exclusion criteria

* Must not be infected with hepatitis B or C. * Patients must not have any acute laboratory abnormality. * Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.

Design outcomes

Primary

Measure	Time frame
Change in viral load	from Day 1 to Day 11
Amount of drug in blood	on Days 1 and 10.

Secondary

Measure	Time frame
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients	throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026