A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmasset
• Treatments: Racivir

Criteria

Inclusion Criteria

Subjects may be eligible to participate if they:

• Are males with HIV infection with a positive HIV antibody test

• Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)

• Have CD4+ cell counts ≥ 50 cells/ml

• Are 18-45 years of age, inclusive

• Have a body mass index (BMI) ≥ 18 kg/m2

• Are antiretroviral nucleoside reverse transcriptase inhibitor-naive

• Have read and understand the informed consent,and is able and willing to comply with study procedures

Exclusion Criteria

Subjects may not participate if they:

• Have clinically significant ECG abnormalities

• Have clinically significant abnormalities in any safety laboratory parameters

• Have an ALT value ≥ 3xUNL

• Have previously participated in this trial

• Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug

• Have a history of chronic alcohol or drug abuse within the last 6 months

• Have a positive urine drug screening

• Have a positive alcohol breath test

• Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial

• Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol