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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Pharmasset


Information provided by (Responsible Party)
Pharmasset
ClinicalTrials.gov Identifier
NCT00040300

First received: June 24, 2002
Last updated: July 18, 2005
Last Verified: July 2005
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections

Drug : Racivir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Pharmasset:

Enrollment: 18
Study Start Date: June 2002
Study Completion Date: December 2002

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040300

Sponsors and Collaborators

Pharmasset
More Information

More Information


Responsible Party: Pharmasset  
ClinicalTrials.gov Identifier: NCT00040300   History of Changes  
Other Study ID Numbers: CI-PSI-004-02-101  
Study First Received: June 24, 2002  
Last Updated: July 18, 2005  

Keywords provided by Pharmasset:

treatment experienced
HIV
Phase I
Combination Therapy

Additional relevant MeSH terms:
HIV Infections
Racivir

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.