Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Glaxo Wellcome |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002373 |
To evaluate the safety and tolerability of multiple escalating doses of 1263W94 administered orally for 28 days in HIV infected patients with asymptomatic CMV shedding. To obtain preliminary evidence of the in vivo anti CMV activity of different doses of 1263W94 in humans based on quantitative reduction of CMV load in semen and if possible in other biological fluids and to explore the dose response relationship in the anti-CMV activity of 1263W94.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Infections HIV Infections |
Drug: Maribavir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase I/II Trial to Evaluate the Tolerability, Anti-CMV Activity and Pharmacokinetics of 1263W94 Following Multiple Oral Administration of Escalating Doses in HIV-Infected Patients With Asymptomatic CMV Shedding |
Estimated Enrollment: | 56 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Stable, chronically administered concomitant therapy for HIV infection and opportunistic diseases if patient has been on the regimen for at least one month prior to study entry.
Patients must have:
Required of Main group:
Required of Satellite group:
Required of both groups:
Prior Medication:
Allowed:
Stable, chronically administered concomitant therapy for HIV infection and opportunistic diseases for at least one month prior.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Systemic therapy for visceral malignancy.
Concurrent Treatment:
Excluded:
Treatment with radiation therapy for visceral malignancy.
Patients with any of the following prior symptoms or conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, California | |
Dr Jacob Lalezari | |
San Francisco, California, United States, 94115 | |
Univ of California/ San Francisco / Dept of Medicine | |
San Francisco, California, United States, 94110 |
Study ID Numbers: | 263A, CMAA1003 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002373 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cytomegalovirus Cytomegalovirus Infections Administration, Oral Acquired Immunodeficiency Syndrome |
Antiviral Agents Virus Shedding Viral Load |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Cytomegalovirus Antiviral Agents Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |
HIV Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections |
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections |