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The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors | Clinical Trials | Clareo Health

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The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors

A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy With 1592U89, 141W94 and DMP 266 in HIV-1 Infected Subjects With Detectable HIV-1 Plasma RNA Despite Treatment With a Protease Inhibitor Containing Regimen

NCT00002213•Glaxo Wellcome

View on ClinicalTrials.gov

Summary

The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir, saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study also examines how long this combination therapy is effective before patients develop resistance to it.

Detailed Description

This is a multicenter, open-label study. A total of 80 patients are treated on this study and include: At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs). All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows: 1592U89 plus 141W94 plus DMP 266.

Eligibility

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Concurrent Medication:
•Allowed:
•Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin.
•Drugs that may interact with CYP3A4, that should be used with caution including (but not limited to):
•alprazolam, carbamazepine, codeine, cimetadine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, itraconazole, ketoconazole, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, quinidine, rifabutin, simvastatin, and warfarin.
•Detoxification treatment including opiate agonists (methadone, buprenorphine, etc.):
•Patients currently receiving this treatment should be enrolled only if stable on this therapy.
•Patients must have:
•HIV-1 infection (all CDC clinical categories allowed).
•HIV-1 RNA greater than 500 copies/ml when measured on 1 occasion within 14 days of study drug administration.
+1 more criteria

Exclusion Criteria

•Co-existing Condition:
•Patients with the following symptoms or conditions are excluded:
•Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption or render the patient unable to take oral medication.
•Active AIDS-defining opportunistic infection or disease that is likely to preclude the patient from study participation.
•Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, would compromise the safety of the patient.
•Concurrent Medication:
•Excluded:
•Immunomodulating agents, e.g., corticosteroids, interleukins, thalidomide, anti-cytokine agents and interferons.
•Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
•Anti-oxidants.
+25 more criteria

Locations (9)

East Bay AIDS Ctr

Berkeley, California, United States

Kraus Med Partners

Los Angeles, California, United States

Northwestern Univ Med School AIDS Treatment Unit

Chicago, Illinois, United States

Niaid / Nih

Bethesda, Maryland, United States

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Saint Vincents Hosp / AIDS Ctr / 4th Floor

New York, New York, United States

Univ of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Univ Int Med Assoc Inc / Holmes Hosp / U of Cincinnati

Cincinnati, Ohio, United States

The Miriam Hosp

Providence, Rhode Island, United States

Key Dates

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Abacavir sulfate

DRUG

Amprenavir

DRUG

Efavirenz

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors

Inclusion Criteria

Exclusion Criteria

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