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Completed

NCT Number: NCT00398125

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

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

Completed

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV-1 Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK364735

Drug

Primary outcomes

  1. Change in viral load

    Time frame: from Day 1 to Day 11

  2. Amount of drug in blood

    Time frame: on Days 1 and 10.

Secondary outcomes

  1. Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Study completion
2007
First posted
Nov 10, 2006
Registry last updated
Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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