NCT00495677
Completed
Phase 2
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
Overview
Brief Summary
To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Asymptomatic HIV-1 infected male patients between the ages of 18 and 55 years inclusive.
- •Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay.
Exclusion Criteria
- •Patients who have received any experimental drug within the past four months (prior to the first dosing day of the study) or who have previously received another CCR5 antagonist.
- •Patients with evidence of decompensated liver disease.
Arms & Interventions
PF-00232798 40 mg
Active Comparator
Intervention: PF-00232798 (Drug)
PF-00232798 300 mg
Active Comparator
Intervention: PF-00232798 (Drug)
PF-00232798 400 mg
Active Comparator
Intervention: PF-00232798 (Drug)
PF-00232798 5 mg
Active Comparator
Intervention: PF-00232798 (Drug)
PF-00232798 20 mg
Active Comparator
Intervention: PF-00232798 (Drug)
PF-00232798 150 mg
Active Comparator
Intervention: PF-00232798 (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
Time Frame: Baseline, Day 11
Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.
Secondary Outcomes
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)(0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10)
- Maximum Observed Plasma Concentration (Cmax)(0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning)
- Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load(Day 1 up to Day 25)
Investigators
Study Sites (1)
Loading locations...
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