Last updated: 11/04/2018 07:59:40
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
GSK study ID
GRZ107460
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 days in HIV-1 Infected Adults.
Trial description: To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change in viral load
Timeframe: from Day 1 to Day 11
Amount of drug in blood
Timeframe: on Days 1 and 10.
Secondary outcomes:
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
Timeframe: throughout the study
Interventions:
Drug: GSK364735
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infection, Human Immunodeficiency Virus
Product
GSK364735
Collaborators
Not applicable
Study date(s)
November 2006 to April 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
- Baseline CD4 cell count greater than 100.
- Must not be infected with hepatitis B or C.
- Patients must not have any acute laboratory abnormality.
Inclusion and exclusion criteria
Inclusion criteria:
- Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
- Baseline CD4 cell count greater than 100.
- Females must be of non-childbearing potential
- Not have received antiretroviral therapy in the 12 weeks prior to first dose.
Exclusion criteria:
- Must not be infected with hepatitis B or C.
- Patients must not have any acute laboratory abnormality.
- Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi’s sarcoma not requiring systemic therapy during the trial.
Trial location(s)
Location
GSK Investigational Site
Hollywood, Florida, United States, 33020
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20007
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32803
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Newark, New Jersey, United States, 07102
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, 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
Not applicable
Actual study completion date
2007-04-04
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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