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A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A 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 website committed to listing clinical research studies in human subjects. A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients Clinical research trials and A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients medical trials happen in hundreds of localities 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 measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients. A 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 permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients clinical trial. Participants frequently obtain the most expert healthcare available for their A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients  A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
A 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 Patients must have: - HIV infection. - Asymptomatic or mildly symptomatic. - CD4 count 100 - 300 cells/mm3. Prior Medication: Allowed: - Prior antiretroviral agents for up to 6 months per agent. 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:
Community Health Network
Rochester, New York, 14620
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
Antibiotic Research Associates
Kansas City, Missouri, 64132
United States
Guthrie Clinic
Sayre, Pennsylvania, 18840
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
Ctr for Special Immunology
Chicago, Illinois, 60657
United States
Independent Investigator
Ft. Lauderdale, Florida, 33316
United States
Clinical Research Ctr
Sarasota, Florida, 34239
United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
California Clinical Trials Med Group
Beverly Hills, California, 90211
United States
Univ Health Ctr
Detroit, Michigan, 48201
United States
Independent Investigator
Vero Beach, Florida, 32960
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33316
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Clinical Investigations Health Services
Mobile, Alabama, 366880002
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359103
United States
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90027
United States
Infectious Disease Associates
Toledo, Ohio, 43608
United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550835
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Additional Information:
Study ID Numbers: 221B; 028574PR0003,NDPR0003
Study Start Date:
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002150
Other Hiv Infections Studies:
1. A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients
2. A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
3. Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV
4. A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
5. Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection
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A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
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