A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
5 other identifiers
interventional
48
1 country
5
Brief Summary
To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral ganciclovir during a 28-day dosing period. Other purposes of the study are to determine in a population of HIV seropositive persons with cytomegalovirus (CMV) viremia, the safety, tolerance, and patient acceptability of oral ganciclovir given for 28 days, to collect preliminary laboratory evidence for antiviral activity and effectiveness of three dose regimens of oral ganciclovir based on blood and urine cultures of CMV, and to relate antiviral activity to dosage and to serum ganciclovir levels. CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS. A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls. More studies are warranted to evaluate effects at different doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Topical acyclovir.
- There are two groups of patients. Group A must have:
- Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.
- A positive urine culture for cytomegalovirus (CMV) within 4 weeks of study entry.
- Not received prior ganciclovir therapy.
- Group B must have:
- A diagnosis of AIDS by CDC criteria.
- CMV retinitis diagnosed on funduscopic evaluation by an ophthalmologist.
- Completed 4 weeks of intravenous ganciclovir with an improvement or stabilization of retinitis. The course of therapy should include a minimum of 24 days total of intravenous ganciclovir.
- Patients in both groups must understand the nature of the study, agree to the tests required in the protocol, and must understand and sign an informed consent form approved by the appropriate Institutional Review Board (IRB) and by Syntex.
- Required:
- Group B:
- weeks of intravenous ganciclovir which should include a minimum of 24 days total of intravenous ganciclovir.
You may not qualify if:
- Co-existing Condition:
- Patients with the following are excluded:
- Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes.
- Active CMV retinitis in which there is progression.
- Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as \> 3 unformed stools/day.
- Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar.
- Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia.
- Concurrent Medication:
- Excluded:
- Any investigational drug.
- Acyclovir not specifically allowed.
- Any other nucleoside analog.
- Zidovudine (AZT).
- Probenecid.
- Aspirin.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Related Publications (2)
Spector SA, et al. Pharmacokinetic, safety and antiviral profile of oral ganciclovir in HIV-infected persons (ACTG 127). Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:154
BACKGROUNDSpector SA, Busch DF, Follansbee S, Squires K, Lalezari JP, Jacobson MA, Connor JD, Jung D, Shadman A, Mastre B, et al. Pharmacokinetic, safety, and antiviral profiles of oral ganciclovir in persons infected with human immunodeficiency virus: a phase I/II study. AIDS Clinical Trials Group, and Cytomegalovirus Cooperative Study Group. J Infect Dis. 1995 Jun;171(6):1431-7. doi: 10.1093/infdis/171.6.1431.
PMID: 7769276BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1995
Last Updated
November 3, 2021
Record last verified: 2021-10