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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000806 |
PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151.
SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity.
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Telinavir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Pharmacokinetics Study |
Official Title: | A Phase I Randomized Dose/Formulation Comparison Study of SC-52151 |
Estimated Enrollment: | 48 |
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Patients are randomized to four treatment arms to receive SC-52151 elixir or SEDDS formulation at 1 of 2 doses for 2 weeks, with follow-up for 14 days.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required for patients with CD4 count <= 200 cells/mm3:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded at any time:
Excluded within 30 days prior to study entry:
Excluded within 14 days prior to study entry:
Excluded within 7 days prior to study entry:
Risk Behavior: Excluded:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Ohio | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 |
Study Chair: | Fischl MA | |
Study Chair: | Richman DD | |
Study Chair: | Flexner C | |
Study Chair: | Para MF |
Study ID Numbers: | ACTG 282 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000806 |
Health Authority: | United States: Federal Government |
Acquired Immunodeficiency Syndrome AIDS-Related Complex HIV Protease Inhibitors |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |