A Study of DPC 817 in HIV-Infected Males

This study has been completed.
Sponsor:
Information provided by:
Pharmasset
ClinicalTrials.gov Identifier:
NCT00040274
First received: June 24, 2002
Last updated: July 18, 2005
Last verified: July 2005
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pharmasset:

Estimated 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00040274     History of Changes
Obsolete Identifiers: NCT00023270
Other Study ID Numbers: DPC 817-201
Study First Received: June 24, 2002
Last Updated: July 18, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmasset:
HIV
Phase I

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 26, 2014