The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors
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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. |
ClinicalTrials.gov Identifier: NCT00002213 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz | Phase 2 |
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.
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 |


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

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 ClinicalTrials.gov identifier (NCT number): NCT00002213
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 |
ClinicalTrials.gov Identifier: | NCT00002213 History of Changes |
Other Study ID Numbers: |
264F CNAA2007 |
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:
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Abacavir Amprenavir Protease Inhibitors HIV Protease Inhibitors 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 |