Last updated: 11/04/2018 08:27:47
A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
GSK study ID
ITG20001
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW810781
Enrollment:
100
Observational study model:
Not applicable
Primary completion date:
2003-31-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
HIV infections
Product
GW810781
Collaborators
Shionogi
Study date(s)
July 2002 to January 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- No prior HIV medications.
- HIV infection with viral load >400-50,000 copies/mL.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Clinical Trials Call Center
West Hollywood, CA, United States, 90069
Status
Study Complete
Location
GSK Clinical Trials Call Center
Altamonte Springs, FL, United States, 32701
Status
Study Complete
Location
GSK Clinical Trials Call Center
New York, NY, United States, 10008
Status
Study Complete
Location
GSK Clinical Trials Call Center
Houston, TX, United States, 77004
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Indianapolis, IN, United States, 46202
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
San Diego, CA, United States, 92103
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
New York, NY, United States, 10032
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Dallas, TX, United States, 75235
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Washington, DC, United States, 20007
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
San Francisco, CA, United States, 94115
Status
Study Complete
Location
GSK Clinical Trials Call Center
Charlotte, NC, United States, 28203
Status
Study Complete
Location
GSK Clinical Trials Call Center
Phoenix, AZ, United States, 85006
Status
Study Complete
Location
GSK Clinical Trials Call Center
Chapel Hill, NC, United States, 27599
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Minneapolis, MN, United States, 55404
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Los Angeles, CA, United States, 90048
Status
Study Complete
Location
GSK Clinical Trials Call Center
Ft. Lauderdale, FL, United States, 33311
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Bronx, NY, United States, 10461
Status
Study Complete
Location
GSK Clinical Trials Call Center
Miami, FL, United States, 33133
Status
Study Complete
Location
GSK Clinical Trials Call Center
Durham, NC, United States, 27710
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Atlanta, GA, United States, 30308
Status
Study Complete
Location
GSK Clinical Trials Call Center
New York, NY, United States, 10011
Status
Study Complete
Location
GSK Clinical Trials Call Center
Tampa, FL, United States, 33614
Status
Terminated/Withdrawn
Location
GSK Clinical Trials Call Center
Denver, CO, United States, 80220
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2003-31-01
Actual study completion date
2003-31-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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