A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir (NCT00000668) | Clinical Trial Compass
CompletedPhase 1
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
United States48 participants
Plain-language 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.
Who can participate
Age range13 Years – 60 Years
SexALL
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Inclusion Criteria
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:
* 4 weeks of intravenous ganciclovir which should include a minimum of 24 days total of intravenous ganciclovir.
Exclusion Criteria
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 oth…
Trial details
NCT IDNCT00000668
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)