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Completed

NCT Number: NCT00046332

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Clinical Trials Call Center, Phoenix, Arizona, 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

  • 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.

Treatment and study plan

GW810781

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Shionogi

Registry information

Official study title

A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Sep 30, 2002
Registry last updated
Feb 21, 2013

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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