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Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) Clinical research trials and Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S). Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) clinical trial. Subjects frequently get the best healthcare possible for their Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S) condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)  Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burden. SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To assess anti-HIV activity using other disease markers. Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.
Details: Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors. Patients are randomized to receive U-90152 at one of three doses (treatment arms I through III) or either AZT or ddI (treatment arm IV). Patients on arm IV who are AZT-naive receive AZT; those who are AZT-experienced receive ddI. Treatment continues for 24 weeks. PER 12/22/94 AMENDMENT: All patients receiving U-90152 have the same starting dose, to attain one of three target trough levels.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - PCP prophylaxis. - Topical antifungal agents, clotrimazole troches, nystatin oral suspension, topical ketoconazole, and oral fluconazole. - Acyclovir (<= 1000 mg/day) as maintenance therapy for herpes simplex virus. - Recombinant erythropoietin and G-CSF. - Antibiotics for bacterial infections, unless specifically excluded. - Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics. - Antacids. Patients must have: - HIV-1 infection. - CD4 count 200 - 500 cells/mm3. - Either no prior antiretroviral therapy or discontinued AZT monotherapy 3 or more weeks prior to study entry. NOTE: - Half of patients should be antiretroviral naive. Prior Medication: Allowed: - Prior AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy other than minimal Kaposi's sarcoma. Concurrent Medication: Excluded: - Rifabutin. - Rifampin. - Terfenadine. - Astemizole. - Loratadine. - Trifluoperazine. - Piperazine citrate. - Any acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection. - Non-study antiretroviral therapies, interferons, biologic response modifiers, and HIV vaccines. - Systemic corticosteroids for more than 21 consecutive days. - Foscarnet. - Systemic cytotoxic chemotherapy for a malignancy. Patients with the following prior conditions are excluded: - History of pancreatitis (in patients who received prior AZT). - History of grade 2 or worse peripheral neuropathy (in patients who received prior AZT). - History of hypersensitivity to BHAP compounds (e.g., trifluoperazine - Stelazine, piperazine citrate - Antepar). Prior Medication: Excluded within 30 days prior to study entry: - Any investigational medication. - Interferon. - Interleukin. - Rifabutin. - Rifampin. - Terfenadine. - Astemizole. - Loratadine. - Trifluoperazine. - Piperazine citrate. Excluded at any time: - Prior ddI, ddC, d4T, or 3TC. - Prior foscarnet. - Prior BHAP compound or other non-nucleoside RT inhibitor. Active substance abuse interfering with compliance.
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
ParaM, Study Chair,
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, 80262
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Rose Med Ctr
Denver, Colorado, 80262
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Additional Information:
Study ID Numbers: ACTG 260;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000810
Other Hiv Infections Studies:
1. A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
2. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination with QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults
3. Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults
4. Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
5. Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
Related Studies:
Other HIV Infections Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
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