A Study of DPC 817 in HIV-Infected Males - Tabular View

Tracking Information
First Received Date ^ICMJE	June 24, 2002
Last Updated Date	July 18, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of DPC 817 in HIV-Infected Males
Official Title ^ICMJE	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
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.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: DPC 817
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany

Administrative Information
NCT ID ^ICMJE	NCT00040274
Responsible Party
Study ID Numbers ^ICMJE	DPC 817-201
Study Sponsor ^ICMJE	Pharmasset
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pharmasset
Verification Date	July 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP