A Study of 141W94 in Combination With Other Anti-HIV Drugs

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002372

Run by

Glaxo Wellcome

People needed

48

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Documented HIV infection.
• CD4+ cell count >= 200 cells/mm3.
• Anticipated need for treatment with cytotoxic chemotherapeutic agents within the study time period.
• Treatment with immunomodulating agents.
• Medications that should not be administered with 141W94:
• Terfenadine. Astemizole. Cisapride. Triazolam. Midazolam. Ergotamine/Dihydroergotamine-containing regimens. Antiretroviral drugs. Vitamin E supplements. Other experimental agents.
• Anticipated need for radiation therapy within the study time period.
• Prior protease inhibitors.
• Antiretroviral therapy within 2 weeks prior to entry.
• Treatment with cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
• 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.

Where it is running

• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• ViRx Inc — San Francisco, California, United States
• Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.