A Study of DPC 817 in HIV-Infected Males

HIV Infections Clinical Trial

Official title:

A Placebo-Controlled, Dose-Escalation Study in HIV-1 Infected Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of DPC 817

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040274
• Other study ID #: DPC 817-201
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2002
• Last updated: July 18, 2005

Study information

• Verified date: July 2005
• Source: Pharmasset
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00023270

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• DPC 817

Locations

Country	Name	City	State
Germany	3ClincalResearch Center	Berlin
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pharmasset

Countries where clinical trial is conducted

United States,  Germany,