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Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen Clinical research trials and Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen. Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen clinical trial. Test subjects typically receive the most expert healthcare available for their Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen
Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen
For Condition: HIV Infections
Status: Completed
Sponsor(s): Berlex Laboratories ,
Synopsis: To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT). Patient must have: - Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks before entry. - Acceptable hepatic and renal function. - AMENDED to delete the following sentence: - Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Concurrent, ineffectively controlled opportunistic infections. - Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy. - Proteinuria of 2+ or greater. - HIV encephalopathy. - HIV wasting syndrome. - New York Heart Classification III or IV. - Uncontrolled angina pectoris. - Evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias. Concurrent Medication: Excluded: - Antiretrovirals other than zidovudine (AZT) or Betaseron. - Chronic acyclovir therapy. - Acetaminophen. Patients with the following are excluded: - Intolerance (hematologic or otherwise) to zidovudine (AZT) at a dose of 100 mg orally every 4 hours. AMENDED to: - Intolerance at a dose of 500 to 600 mg/day. - Medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study. Prior Medication: Excluded within 30 days of study entry: - Cytotoxic chemotherapy. - Prior therapy with alpha, beta, or gamma interferons. Active drug or alcohol abuse.
Total Enrollment:
Location and Contact Information:
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Univ of South Florida
Tampa, Florida, 33612
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Dr Douglas Dieterich
New York City, New York, 10016
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Alta Bates / Herrick Hosp
Berkeley, California, 94704
United States
Dr William Davis
Washington D.C., District of Columbia, 20016
United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Chelsea Village Med Ctr
New York City, New York, 10014
United States
Santa Clara Valley Med Ctr
San Jose, California, 95128
United States
UCI Med Ctr
Orange, California, 92668
United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: 002A; TBO1-310188
Study Start Date:
Record last reviewed: April 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002238
Other Hiv Infections Studies:
1. A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
2. The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients
3. Study of Itraconazole in Patients with Advanced HIV Infection
4. A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
5. Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
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Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen
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