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

This study has been completed.
Sponsor:
Information provided by:
Pharmasset
ClinicalTrials.gov Identifier:
NCT00040300
First received: June 24, 2002
Last updated: July 18, 2005
Last verified: July 2005

June 24, 2002
July 18, 2005
June 2002
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Complete list of historical versions of study NCT00040300 on ClinicalTrials.gov Archive Site
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A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
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The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Drug: Racivir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2002
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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
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00040300
CI-PSI-004-02-101
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Pharmasset
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Pharmasset
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP