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

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00046332
First received: September 26, 2002
Last updated: February 20, 2013
Last verified: February 2013

September 26, 2002
February 20, 2013
June 2002
January 2003   (final data collection date for primary outcome measure)
Plasma HIV-1 RNA change from baseline by Day 11.
Not Provided
Complete list of historical versions of study NCT00046332 on ClinicalTrials.gov Archive Site
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.
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A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: GW810781
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2003
January 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00046332
ITG20001
Not Provided
Not Provided
GlaxoSmithKline
Shionogi
Study Director: GSK Clinical Trial, MD,MPH GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP