A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males - Tabular View

Tracking Information
First Received Date ^ICMJE	June 24, 2002
Last Updated Date	July 18, 2005
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
Official Title ^ICMJE
Brief Summary	The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.
Detailed Description	The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Racivir
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	18
Completion Date	December 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Subjects may be eligible to participate if they: Are males with HIV infection with a positive HIV antibody test Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay) Have CD4+ cell counts ≥ 50 cells/ml Are 18-45 years of age, inclusive Have a body mass index (BMI) ≥ 18 kg/m2 Are antiretroviral nucleoside reverse transcriptase inhibitor-naive Have read and understand the informed consent,and is able and willing to comply with study procedures Exclusion Criteria Subjects may not participate if they: Have clinically significant ECG abnormalities Have clinically significant abnormalities in any safety laboratory parameters Have an ALT value ≥ 3xUNL Have previously participated in this trial Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug Have a history of chronic alcohol or drug abuse within the last 6 months Have a positive urine drug screening Have a positive alcohol breath test Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject’s ability to participate in this trial Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol
Gender	Male
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00040300
Responsible Party
Study ID Numbers ^ICMJE	CI-PSI-004-02-101
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