Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Glaxo Wellcome |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002335 |
To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients.
To determine the effects of food on bioavailability of 524W91.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Emtricitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control, Pharmacokinetics Study |
Official Title: | A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91 |
Estimated Enrollment: | 18 |
Patients are randomized to receive six single escalating doses of 524W91 or placebo, with each dose separated by at least a 6-day washout interval. In the time between 2 of the doses, the effect of food on pharmacokinetics will be investigated, with one dose administered in conjunction with a high-fat meal and one dose administered in a fasted state.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded on the day of each dose:
Patients with the following prior conditions are excluded:
History of hepatitis, pancreatitis, or cardiomyopathy within the past 5 years.
Prior Medication:
Excluded:
Study ID Numbers: | 233A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002335 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
Virus Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Emtricitabine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex 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 Emtricitabine HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |