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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002213
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing 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, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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.

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:


  • 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:


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:


  • 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).

Prior Treatment:


Radiation therapy.


  • Treatment with at least 1 of the following protease inhibitors (PIs) for a minimum of 20 weeks prior to screening:

indinavir, ritonavir, saquinavir, and/or nelfinavir.

  • Treatment with the same combination of PIs for the most recent 12 weeks and up through entry on study (Day 1).

Active alcohol or illicit drug use that is likely to interfere with dosing schedule compliance and protocol evaluations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002213

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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 Collaborators
Glaxo Wellcome
Layout table for additonal information Identifier: NCT00002213    
Other Study ID Numbers: 264F
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1998
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Antiviral Agents
HIV Protease Inhibitors
RNA, Viral
VX 478
Anti-HIV Agents
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-HIV Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
HIV Protease Inhibitors