Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression

NACompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

November 30, 2006

Study Completion Date

November 30, 2006

Conditions
HIV InfectionsAIDS
Interventions
DRUG

Tenofovir

Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir.

DRUG

Hydroxyurea

Half of the 20 volunteers will be randomized to the Tenofovir 300 mg qd/Hydroxyurea 500mg qd arm and those subjects will have Hydroxyurea added to their current screening regimen for 4 weeks prior to de-intensifying to Hydroxyurea and Tenofovir. Volunteers will continue on this regimen for 48 weeks. Patients will be monitored for immunological and virological parameters as well as the incidence of toxicity and side effects during the study. If a patient's viral load reaches \>400 copies/ml on 3 consecutive measurements over a 6 week period, they will be terminated from the study and started back on their HAART.

Trial Locations (1)

21201

University of Maryland, Institute of Human Virology, Baltimore

All Listed Sponsors
lead

University of Maryland, Baltimore

OTHER

NCT00344981 - Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression | Biotech Hunter | Biotech Hunter