drugset / Trial / NCT00002396

The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients

NCT00002396

Phase 1 Unknown 60 enrolled Gilead Sciences
Double-blindTreatment

Summary

To evaluate the safety of single and multiple doses (28 daily doses) of 9-\[2-(R)-\[\[bis\[\[(isopropoxycarbonyl)- oxy\]methoxy\]phosphinoyl\]methoxy\]propyl\]adenine fumarate (PMPA) prodrug administered orally to HIV-infected patients. To determine the pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to HIV-infected patients. To evaluate the anti-HIV activity of PMPA prodrug, as demonstrated by increases in CD4 cell counts and decreases in HIV RNA, when administered orally as a single dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more cells/mm3.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir disoproxil fumarate Small molecule Oral