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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002213

Run by

Glaxo Wellcome

People needed

80

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Signed, informed consent from parent or legal guardian for those patients under 18 years of age.

You may not qualify if…

• 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.
• Foscarnet therapy or therapy with other agents with documented activity against HIV-1 in vitro.
• Medications that interact with 141W94:
• terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.
• Vitamin E supplements.
• Other investigational treatments (treatments available through Treatment IND or other expanded access mechanism evaluated on an individual basis).
• Concurrent Treatment:
• Excluded:
• Anticipated need for radiation therapy (with the exception of local treatment for Kaposi's sarcoma).
• Patients with the following symptoms and conditions are excluded:
• History of clinically relevant hepatitis within the previous six months.
• History of lymphoma.
• Prior Medication:
• Excluded:
• Cytotoxic chemotherapeutic agents within 30 days of study drug administration or an anticipated need for such treatment within the next 48 weeks (with exception of local treatment for Kaposi's sarcoma).
• Investigational HIV-1 vaccine trial and receipt of a dose of vaccine within the past 3 months.

Where it is running

• 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

Full record on ClinicalTrials.gov

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