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

NCT ID: NCT00398125

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GSK364735

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Denver, Colorado, United States

Site Status

GSK Investigational Site

Washington D.C., District of Columbia, United States

Site Status

GSK Investigational Site

Fort Lauderdale, Florida, United States

Site Status

GSK Investigational Site

Hollywood, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Newark, New Jersey, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GRZ107460

Identifier Type: -

Identifier Source: org_study_id

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