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

July 18, 2005 updated by: Pharmasset
The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmasset

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

June 24, 2002

First Submitted That Met QC Criteria

June 24, 2002

First Posted (Estimate)

June 25, 2002

Study Record Updates

Last Update Posted (Estimate)

July 21, 2005

Last Update Submitted That Met QC Criteria

July 18, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-PSI-004-02-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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