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A Study of DPC 817 in HIV-Infected Males

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DPC 817
Sponsored by
Pharmasset
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Phase I

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina Hospitals
  • 3ClincalResearch Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 24, 2002
Last Updated
July 18, 2005
Sponsor
Pharmasset
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1. Study Identification

Unique Protocol Identification Number
NCT00040274
Brief Title
A Study of DPC 817 in HIV-Infected Males
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmasset

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Phase I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DPC 817

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
3ClincalResearch Center
City
Berlin
Country
Germany

12. IPD Sharing Statement

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A Study of DPC 817 in HIV-Infected Males

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