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

Sponsor

Pharmasset (Industry)

Overall Status

Completed

CT.gov ID

NCT00040300

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Racivir	Phase 1

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Jun 1, 2002

Study Completion Date :

Dec 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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