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Sponsored by: |
Pharmasset |
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Information provided by: | Pharmasset |
ClinicalTrials.gov Identifier: | NCT00040300 |
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 |
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HIV Infections |
Drug: Racivir |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study |
Estimated Enrollment: | 18 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | December 2002 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Subjects may be eligible to participate if they:
Exclusion Criteria
Subjects may not participate if they:
Study ID Numbers: | CI-PSI-004-02-101 |
Study First Received: | June 24, 2002 |
Last Updated: | July 18, 2005 |
ClinicalTrials.gov Identifier: | NCT00040300 History of Changes |
Health Authority: | United States: Food and Drug Administration |
treatment experienced HIV Phase I Combination Therapy |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Antiviral Agents 2',3'-dideoxy-5-fluoro-3'-thiacytidine Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections 2',3'-dideoxy-5-fluoro-3'-thiacytidine |