The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: March 1998
History of Changes
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.
Drug : Abacavir sulfate
Drug : Amprenavir
Drug : Efavirenz
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
This is a multicenter, open-label study. A total of 80 patients are treated on this study and
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.
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
- Immunomodulating agents, e.g., corticosteroids, interleukins, thalidomide, anti-cytokine agents and interferons.
- Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
- 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).
- History of clinically relevant hepatitis within the previous six months.
- History of lymphoma.
- 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.
- Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study drug administration.
- Exposure to the investigational agents 1592U89, 141W94, or DMP 266 (Sustiva).
- Treatment with at least 1 of the following protease inhibitors (PIs) for a minimum of 20 weeks prior to screening:
- Treatment with the same combination of PIs for the most recent 12 weeks and up through
Patients must have:
Patients with the following symptoms or conditions are 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:
indinavir, ritonavir, saquinavir, and/or nelfinavir.
Active alcohol or illicit drug use that is likely to interfere with dosing schedule compliance and protocol evaluations.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002213
Locations Show More
|United States, California|
|East Bay AIDS Ctr|
|Berkeley, California, United States, 94705|
|Kraus Med Partners|
|Los Angeles, California, United States, 90036|
|United States, Illinois|
|Northwestern Univ Med School AIDS Treatment Unit|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Niaid / Nih|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Beth Israel Deaconess Med Ctr|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Saint Vincents Hosp / AIDS Ctr / 4th Floor|
|New York, New York, United States, 10011|
|United States, North Carolina|
|Univ of North Carolina Chapel Hill|
|Chapel Hill, North Carolina, United States, 27499|
|United States, Ohio|
|Univ Int Med Assoc Inc / Holmes Hosp / U of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|United States, Rhode Island|
|The Miriam Hosp|
|Providence, Rhode Island, United States, 02906|
Sponsors and CollaboratorsGlaxo Wellcome
|Responsible Party:||Glaxo Wellcome|
|ClinicalTrials.gov Identifier:||NCT00002213 History of Changes|
|Other Study ID Numbers:||264F|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Additional relevant MeSH terms:
HIV Protease Inhibitors
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.