The Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients
|First Received Date ICMJE||November 2, 1999|
|Last Updated Date||June 23, 2005|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00002373 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients|
|Official Title ICMJE||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|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Maribavir|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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:
Stable, chronically administered concomitant therapy for HIV infection and opportunistic diseases for at least one month prior.
Patients with any of the following symptoms or conditions are excluded:
Systemic therapy for visceral malignancy.
Treatment with radiation therapy for visceral malignancy.
Patients with any of the following prior symptoms or conditions are excluded:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00002373|
|Other Study ID Numbers ICMJE||263A, CMAA1003|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Glaxo Wellcome|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||NIH AIDS Clinical Trials Information Service|
|Verification Date||November 1998|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP