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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002213
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1998
  Purpose

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 Intervention Phase
HIV Infections
Drug: Abacavir sulfate
Drug: Amprenavir
Drug: Efavirenz
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 80
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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:

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.
  • 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:

Excluded:

Radiation therapy.

Required:

  • 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002213

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002213     History of Changes
Other Study ID Numbers: 264F, CNAA2007
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
Antiviral Agents
HIV Protease Inhibitors
RNA, Viral
VX 478
Anti-HIV Agents
abacavir
efavirenz

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antiviral Agents
Amprenavir
Efavirenz
Abacavir
Protease Inhibitors
HIV Protease Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014