A Study of 141W94 in Combination With Other Anti-HIV Drugs
NCT ID: NCT00002372
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Indinavir sulfate
Amprenavir
Nelfinavir mesylate
Saquinavir
Eligibility Criteria
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Inclusion Criteria
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.
1\. 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.
1\. 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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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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
Countries
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References
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Eron JJ, Haubrich R, Lang W, Pagano G, Millard J, Wolfram J, Snowden W, Pedneault L, Tisdale M. A phase II trial of dual protease inhibitor therapy: amprenavir in combination with indinavir, nelfinavir, or saquinavir. J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):458-61. doi: 10.1097/00126334-200104150-00008.
Other Identifiers
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264A
Identifier Type: -
Identifier Source: org_study_id