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A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients Clinical research trials and A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients. A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients  A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoechst Marion Roussel ,
Synopsis: To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Prior antiretroviral agents for up to 6 months per agent. Patients must have: - HIV infection. - Asymptomatic or mildly symptomatic. - CD4 count 301 - 500 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: Unable or unwilling to comply with study procedures. Concurrent Medication: Excluded: - Chemoprophylactic therapy for mycobacterial infection. - Any nonstudy prescription medications without approval of investigator. Patients with the following prior conditions are excluded: - History of grade 3 or 4 toxicity to <= 600 mg/day AZT. - History of intolerance to lactose. - Chronic diarrhea within 6 months prior to study entry. - Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry. Prior Medication: Excluded: - Antiretroviral therapy within 2 weeks prior to study entry. - Prior HIV vaccines. - Biological response modifiers within 30 days prior to study entry. - Prior foscarnet. - Any investigational drug with a washout < 5 half-lives prior to study entry. - Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry. Recent history of alcohol and/or drug abuse.
Total Enrollment: 200
Location and Contact Information:
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
Antibiotic Research Associates
Kansas City, Missouri, 64132
United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550835
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33316
United States
Clinical Investigations Health Services
Mobile, Alabama, 366880002
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Ctr for Special Immunology
Chicago, Illinois, 60657
United States
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, 70112
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Clinical Research Ctr
Sarasota, Florida, 34239
United States
Univ Health Ctr
Detroit, Michigan, 48201
United States
Independent Investigator
Vero Beach, Florida, 32960
United States
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90027
United States
Community Health Network
Rochester, New York, 14620
United States
Guthrie Clinic
Sayre, Pennsylvania, 18840
United States
Infectious Disease Associates
Toledo, Ohio, 43608
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359103
United States
Independent Investigator
Ft. Lauderdale, Florida, 33316
United States
California Clinical Trials Med Group
Beverly Hills, California, 90211
United States
Additional Information:
Study ID Numbers: 221C; 028574PR0004,NDPR0004
Study Start Date:
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002151
Other Hiv Infections Studies:
1. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
2. Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
3. Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328
4. A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
5. A Study of ABT-378/Ritonavir in HIV-Infected Patients
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A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
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