|
The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms 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 HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms Clinical research trials and The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms 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 HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms. The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms 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 HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms 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.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms  The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoechst Marion Roussel ,
Synopsis: To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone. PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.
Details: Patients are randomized to receive one of three doses of HBY 097 with or without AZT or AZT alone for 12 weeks (AZT monotherapy arm eliminated per 1/19/96 amendment). All patients at a given dose level of HBY 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. Additional patients are entered at the optimal dose of HBY 097. Patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks. PER AMENDMENT: Enrollment to the lowest dose cohort is completed.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Treatment for opportunistic infection that develops on study. Recommended: - PCP prophylaxis if CD4 count falls below 200 cells/mm3. Patients must have: - HIV infection. - CD4 count 200 - 500 cells/mm3. - HIV-1 RNA PCR value of 10000 copies/ml or higher. - Asymptomatic or mildly symptomatic disease. - No past or current AIDS-defining event. - Consent of parent or guardian if less than legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Endocrine, hepatic, renal, or gastrointestinal disease. - Cardiovascular conduction disease. - Concomitant medical illness that may complicate study conduct or interpretation of results. - Other factors that may interfere with patient compliance. Concurrent Medication: Excluded: - Antiretroviral agents other than study drugs. - Oral contraceptives. - Cytotoxic chemotherapy. - Immunomodulators. - Antiproliferative agents. - Corticosteroids. - Anabolic steroids. - Estrogens. - Quinoxaline derivatives. Concurrent Treatment: Excluded: - Radiation therapy. Patients with the following prior conditions are excluded: - History of hypersensitivity to quinoxaline derivatives or intolerance to AZT. - History of cardiovascular conduction disease. - Prior participation in this study or any study using HBY 097. - Recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion. - History of thyroid disease. Prior Medication: Excluded at any time: Prior non-nucleoside reverse transcriptase inhibitors. Excluded within 30 days prior to study entry: - Any antiretroviral therapy. - Oral contraceptives. - Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons. - Cytotoxic chemotherapeutic agents. - Other investigational drugs. Excluded within 6 months prior to study entry: Immunotherapeutic vaccine. Prior Treatment: Excluded within 30 days prior to study entry: - Radiation therapy. - An experimental device. Current ethanol or illicit drug abuse.
Total Enrollment: 144
Location and Contact Information:
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Stanford Univ School of Medicine
Stanford, California, 943055107
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
Additional Information:
Study ID Numbers: 252A; HBY097/2001
Study Start Date:
Record last reviewed: May 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002357
Other Hiv Infections Studies:
1. A Study of HIV-Disease Development in Aging
2. A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients
3. The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients
4. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
5. Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Georgia Clinical Trials
Other Augusta Clinical Trials
The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
|
|
|
|
|
|
|
|
