Tolerability, Anti-CMV Activity and Pharmacokinetics of 1263W94 in HIV-Infected Patients With Asymptomatic CMV Shedding
This study aims to evaluate the safety, tolerability, and effectiveness of the drug 1263W94 in treating CMV infection in HIV-positive patients who are asymptomatic for CMV shedding.
Maribavir
Blood-Borne Infections+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
HIV seropositive men stratified based on CMV titer in semen at the Pre-Screen visit (30 days prior to entry). Patients with a CMV titer >= 5000 PFU/ml and a positive result upon qualitative urine CMV culture may be eligible for entry into the main group and patients with a CMV titer < 5000 PFU/ml may be eligible for entry into the satellite group. Patients will on 1263W94 for 4 weeks. Patients will be present for clinic visits on study days 1, 7, 14, 21, and 28. They will return to the clinic for post treatment evaluations on study days 42 and 56.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.56 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Univ of California/ San Francisco / Dept of Medicine
San Francisco, United StatesOpen Univ of California/ San Francisco / Dept of Medicine in Google MapsDr Jacob Lalezari
San Francisco, United States