A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
This study has been completed.
Sponsor:
GlaxoSmithKline
Collaborator:
Shionogi
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00046332
First received: September 26, 2002
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: GW810781 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Plasma HIV-1 RNA change from baseline by Day 11.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2002 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046332
Locations
| United States, Arizona | |
| GSK Clinical Trials Call Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| GSK Clinical Trials Call Center | |
| Los Angeles, California, United States, 90048 | |
| GSK Clinical Trials Call Center | |
| San Diego, California, United States, 92103 | |
| GSK Clinical Trials Call Center | |
| San Francisco, California, United States, 94115 | |
| GSK Clinical Trials Call Center | |
| West Hollywood, California, United States, 90069 | |
| United States, Colorado | |
| GSK Clinical Trials Call Center | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| GSK Clinical Trials Call Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| GSK Clinical Trials Call Center | |
| Altamonte Springs, Florida, United States, 32701 | |
| GSK Clinical Trials Call Center | |
| Ft. Lauderdale, Florida, United States, 33311 | |
| GSK Clinical Trials Call Center | |
| Miami, Florida, United States, 33133 | |
| GSK Clinical Trials Call Center | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| GSK Clinical Trials Call Center | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Indiana | |
| GSK Clinical Trials Call Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Minnesota | |
| GSK Clinical Trials Call Center | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New York | |
| GSK Clinical Trials Call Center | |
| Bronx, New York, United States, 10461 | |
| GSK Clinical Trials Call Center | |
| New York, New York, United States, 10008 | |
| GSK Clinical Trials Call Center | |
| New York, New York, United States, 10032 | |
| GSK Clinical Trials Call Center | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| GSK Clinical Trials Call Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| GSK Clinical Trials Call Center | |
| Charlotte, North Carolina, United States, 28203 | |
| GSK Clinical Trials Call Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| GSK Clinical Trials Call Center | |
| Dallas, Texas, United States, 75235 | |
| GSK Clinical Trials Call Center | |
| Houston, Texas, United States, 77004 | |
Sponsors and Collaborators
GlaxoSmithKline
Shionogi
Investigators
| Study Director: | GSK Clinical Trial, MD,MPH | GlaxoSmithKline |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00046332 History of Changes |
| Other Study ID Numbers: | ITG20001 |
| Study First Received: | September 26, 2002 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Integrase inhibitors Monotherapy HIV-1 infection |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013