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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT00046332 |
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Date of registration:
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26/09/2002 |
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Primary sponsor: |
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Public title:
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A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
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Scientific title:
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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. |
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Date of first enrolment:
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June 2002 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00046332 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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GSK Clinical Trial, MD,MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: GW810781
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Primary Outcome(s)
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Plasma HIV-1 RNA change from baseline by Day 11.
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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