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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 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| Cedars Sinai Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| 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
| Study ID Numbers: | 002A, TBO1-310188 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002238 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Interferon Type I |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Zidovudine Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Interferons Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Interferon-beta Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Interferon beta-1b |