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| Sponsored by: |
Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002372 |
Purpose
To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing. To determine the steady-state pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when combined with saquinavir, indinavir and nelfinavir.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate Drug: Saquinavir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | A Phase I/II Screening Trial to Identify Potential Partner Compounds to Use in Combination With 141W94 |
| Estimated Enrollment: | 48 |
Patients will be randomized to receive open label 141W94 in combination with saquinavir, indinavir and nelfinavir. The randomized phase will be preceded by a single dose pharmacokinetic interaction study of 141W94 and indinavir in 12 patients. Data from this single dose investigation will be used to determine the dose of indinavir to be used in the randomized phase.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed provided used with caution:
Medications that may interact at CYP3A4 (either a substrate, inhibitor or inducer of the enzyme) should be used with caution.
Patients must have:
CD4+ cell count >= 200 cells/mm3.
1. Anticipated need for treatment with cytotoxic chemotherapeutic agents within the study time period.
Anticipated need for radiation therapy within the study time period.
1. Prior protease inhibitors.
Radiation therapy within 4 weeks prior to entry. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing and protocol evaluations.
Contacts and Locations| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 92103 | |
| ViRx Inc | |
| San Francisco, California, United States, 94109 | |
| United States, North Carolina | |
| Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
More Information
| Study ID Numbers: | 264A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002372 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Administration, Oral HIV Protease Inhibitors Indinavir |
Saquinavir Nelfinavir VX 478 |
|
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Indinavir Saquinavir Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors |
Virus Diseases Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Antitubercular Agents Nelfinavir Retroviridae Infections |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Saquinavir Infection Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Antitubercular Agents |
