Completed

Tolerability, Anti-CMV Activity and Pharmacokinetics of 1263W94 in HIV-Infected Patients With Asymptomatic CMV Shedding

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Study Aim

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.

What is being tested

Maribavir

Drug
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002373
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsHIV Infections

Criteria

8 inclusion criteria required to participate
Minimum CMV titer of 5000 PFU/ml in semen by quantitative CMV culture on one occasion within 30 days of entry.
Demonstrating positive result of qualitative CMV culture in urine on one occasion within 30 days of entry.
Must have CD4+ < 150 c/mm3 (or 10% of total lymphocytes) at screen.
Stable, chronically administered concomitant therapy for HIV infection and opportunistic diseases for at least one month prior.
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17 exclusion criteria prevent from participating
History of CMV disease (such as retinitis, colitis, encephalitis, pneumonitis, etc.)
Treatment with radiation therapy for visceral malignancy within 2 months prior to entry.
Patients who are so debilitated as a result of their HIV disease or associated illness or therapies such that, in the investigator's opinion, the condition may interfere with the study assessments or the patient's ability to complete the entire study per protocol requirements.
Diagnosis of chronic diseases such as diabetes or hypoglycemia, epilepsy, ongoing Grade II peripheral neuropathy, congestive heart failure, cardiomyopathy, other organ dysfunctions, etc., which in the opinion of the investigator, would compromise the safety or compliance of the patient.
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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 Maps

Dr Jacob Lalezari

San Francisco, United States
Completed2 Study Centers