Phase 2
Completed N=20
A Phase 2 Study Of PF-00232798 In HIV Positive Patients
Source: ClinicalTrials.gov NCT00495677 ↗Enrolled (actual)
20
Serious AEs
4.7%
Results posted
Oct 2013
Primary outcomePrimary: Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11 — 4.692; 4.338; 4.306; 4.483 log10 copies/mL
Summary
To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11 |
4.692; 4.338; 4.306; 4.483; 4.315; 4.715 | — |
| SECONDARY Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
25.21; 185.57; 379.27; 2675.57; 3793.01; 4802.57 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
3.0000; 1.0330; 4.0000; 3.0415; 2.0000; 2.0000 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) |
265.3; 1157.4; 2945.1; 17319.1; 28347.9; 41027.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00495677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.