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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors Clinical research trials and The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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 Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > 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 Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors
The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients with HIV Who Developed a Resistance to Protease Inhibitors
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 80
Location and Contact Information:
Univ of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27499
United States
NIAID / NIH
Bethesda, Maryland, 20892
United States
Univ Int Med Assoc Inc / Holmes Hosp / U of Cincinnati
Cincinnati, Ohio, 45267
United States
Northwestern Univ Med School AIDS Treatment Unit
Chicago, Illinois, 60611
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
The Miriam Hosp
Providence, Rhode Island, 02906
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Kraus Med Partners
Los Angeles, California, 90036
United States
Saint Vincents Hosp / AIDS Ctr / 4th Floor
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: 264F; CNAA2007
Study Start Date:
Record last reviewed: March 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002213
Other Hiv Infections Studies:
1. Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals
2. Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
3. A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
4. A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in Patients With AIDS Post First Episode PCP
5. Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults
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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
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