A Study of DPC 817 in HIV-Infected Males

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied.

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

Details

• Lead Sponsor: Pharmasset
• Treatments: Dexelvucitabine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV positive

• Are male and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age

• Are female and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age and are not able to have children (females may participate in Part B only)

• Have no clinically significant findings on physical examination or clinical laboratory evaluations

• Have a CD4-lymphocyte count of 50 or more cells/mm3

• Are able and willing to comply with the requirements of this study

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have an opportunistic infection characteristic of AIDS

• Are receiving any approved or experimental HIV drugs. Any previous anti-HIV treatment must be stopped at least 4 weeks before the first dose of study medication

• Are pregnant or breast-feeding

• Are enrolled in other experimental drug studies or have recieved other experimental drugs within 30 days before the first dose of study drug

• Have any disease that causes a problem with absorption of drugs

• Have active hepatitis

• Have a history of pancreatitis or peripheral neuropathy

• Have received radiation therapy or chemotherapy within 30 days before the first dose of study drug

• Have received treatment with drugs that affect the immune system within 30 days before the first dose of study drug or have received an HIV immunotherapeutic vaccine

• Have taken prescription or over-the-counter products within 14 days of the first dose of study drug unless approved by the doctor

• Are unable to comply with the dosing schedule and study procedures