A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
Status:
Completed
Trial end date:
1995-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)