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Clinical Trials

MainTitle

A Study of DPC 817 in HIV-Infected Males

This study has been completed
Sponsor
Pharmasset


Information provided by (Responsible Party)
Pharmasset
ClinicalTrials.gov Identifier
NCT00040274

First received: June 24, 2002
Last updated: July 18, 2005
Last Verified: July 2005
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : DPC 817
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Further study details as provided by Pharmasset:

Enrollment: 30

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 55 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040274

Locations

United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
Germany
3ClincalResearch Center
Berlin, Germany

Sponsors and Collaborators

Pharmasset
More Information

More Information


Responsible Party: Pharmasset  
ClinicalTrials.gov Identifier: NCT00040274   History of Changes  
Other Study ID Numbers: DPC 817-201  
Study First Received: June 24, 2002  
Last Updated: July 18, 2005  

Keywords provided by Pharmasset:

HIV
Phase I

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.