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| Sponsor: | Bayer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002238 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Interferon beta-1b Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patient must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 30 days of study entry:
Active drug or alcohol abuse.
Contacts and Locations| United States, California | |
| Alta Bates / Herrick Hosp | |
| Berkeley, California, United States, 94704 | |
| USC School of Medicine / Norris Cancer Hosp | |
| Los Angeles, California, United States, 90033 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Cedars Sinai Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 95128 | |
| United States, District of Columbia | |
| Dr William Davis | |
| Washington, District of Columbia, United States, 20016 | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New York | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Chelsea Village Med Ctr | |
| New York, New York, United States, 10014 | |
| Beth Israel Med Ctr / Peter Krueger Clinic | |
| New York, New York, United States, 10003 | |
| Dr Douglas Dieterich | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Univ Hosp of Cleveland / Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Graduate Hosp | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| Thomas Jefferson Med College | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Saint Christopher's Hosp for Children | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, Texas | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002238 History of Changes |
| Other Study ID Numbers: | 002A, TBO1-310188 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Interferon Type I |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Interferon-beta Interferons Zidovudine Interferon beta-1b |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Anti-HIV Agents Adjuvants, Immunologic |