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

Phase 2

Completed

• Conditions: Infection, Human Immunodeficiency Virus; HIV-1 Infection

• Registration Number: NCT00398125
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-10
• Study Completion: 2007-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-26
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Dallas, Texas, United States