The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors
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
2 other identifiers
interventional
80
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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).
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (9)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Kraus Med Partners
Los Angeles, California, 90036, United States
Northwestern Univ Med School AIDS Treatment Unit
Chicago, Illinois, 60611, United States
Niaid / Nih
Bethesda, Maryland, 20892, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Saint Vincents Hosp / AIDS Ctr / 4th Floor
New York, New York, 10011, United States
Univ of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27499, United States
Univ Int Med Assoc Inc / Holmes Hosp / U of Cincinnati
Cincinnati, Ohio, 45267, United States
The Miriam Hosp
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-03