A Study of DPC 817 in HIV-Infected Males - Full Text View

Sponsored by:	Pharmasset
Information provided by:	Pharmasset
ClinicalTrials.gov Identifier:	NCT00040274

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: 2',3'-Dideoxy-2',3'-didehydro-5-fluorocytidine Elvucitabine

U.S. FDA Resources

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

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

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

Keywords provided by Pharmasset:

HIV
Phase I

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on July 02, 2009