The Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients

NCT00002373 | Completed Phase 1

• 2 other identifiers: 263ACMAA1003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cytomegalovirus Infections; HIV Infections

Keywords

Cytomegalovirus; Cytomegalovirus Infections; Administration, Oral; Acquired Immunodeficiency Syndrome; Antiviral Agents; Virus Shedding; Viral Load

Interventions

Maribavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Required of Satellite group:
• Must have CD4+ \< 150 c/mm3 (or 10% of total lymphocytes) at screen.
• Required of both groups:
• HIV infection.
• Life expectancy \> 6 months.
• Able to comply with protocol requirements/instructions and likely to complete all study visits and evaluations as planned.
• Prior Medication:
• Allowed:

You may not qualify if:

• Co-existing Condition:
• Patients with any of the following symptoms or conditions are excluded:
• Active CMV disease (retinitis, colitis, encephalitis, pneumonitis, etc.).
• Visual symptoms or signs suggestive of CMV disease (e.g., floaters, visual field defects, decreased visual acuity); Unless CMV disease is excluded via ophthalmoscopy examination.
• Active hepatitis, obstructive hepatobiliary diseases or cirrhosis.
• Gastrointestinal disorders which, in the judgement of the investigator, might interfere with oral dosing and drug absorption or may be indicative of CMV disease e.g., chronic nausea or vomiting, active bowel disease or persistent diarrhea.
• 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.
• Participation in other investigational trials.
• 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.
• Concurrent Medication:
• Excluded:
• Systemic therapy for visceral malignancy.
• Concurrent Treatment:
• Excluded:
• Treatment with radiation therapy for visceral malignancy.

Sponsors & Collaborators

• Glaxo Wellcome: lead

Study Sites (2)

Univ of California/ San Francisco / Dept of Medicine

San Francisco, California, 94110, United States

Location

Dr Jacob Lalezari

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

maribavir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-11

Locations

US (2)