A Study of DPC 817 in HIV-Infected Males

Pharmasset

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: DPC 817

Study type

Interventional

Funder types

Industry

Identifiers

NCT00040274

DPC 817-201

Details and patient eligibility

About

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

Full description

The study will consist of two parts. Patients in Part A will receive a single dose of DPC 817 on two separate occasions and a placebo (a solution or tablet without the drug) on one occasion. Patients in Part B will receive two separate doses of DPC 817. Patients will be admitted to the clinical study unit the day before dosing (Day -1) and remain there for at least 48 hours after taking the study drug. Patients will return to the clinical study unit on Day 8 and Day 28 following the dose in the last treatment period. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, and routine clinical laboratory tests.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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