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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002086 |
Purpose
Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to >= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only.
Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease. To determine the effect of these regimens on secondary measures of clinical status (e.g., performance score, weight change, and secondary infections) and on measures of virologic activity such as serum p24 antigen. To assess the safety and tolerance of these regimens.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: Zalcitabine Drug: Interferon alfa-n1 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Safety Study |
| Official Title: | A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Patients < 18 years of age must have written consent of parent or guardian. The effects of the combination therapy on infants or the developing fetus are unknown. Patients are encouraged to utilize adequate contraception while enrolled in the study.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and Locations| United States, California | |
| ViRx Inc | |
| San Francisco, California, United States, 94103 | |
| Marin County Specialty Clinic | |
| San Rafael, California, United States, 94903 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33612 | |
| Stratogen of South Florida | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Indiana | |
| Infectious Diseases Research Clinic / Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, New York | |
| North Shore Univ Hosp / Div of Infectious Diseases | |
| Manhasset, New York, United States, 11030 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670560 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Vanderbilt School of Medicine | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Univ of Utah School of Medicine | |
| Salt Lake City, Utah, United States, 84132 | |
More Information
| Study ID Numbers: | 052C, 03 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002086 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Zalcitabine Drug Therapy, Combination AIDS-Related Complex Zidovudine Interferon-alpha |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Interferon Type I, Recombinant Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections Nucleic Acid Synthesis Inhibitors Interferon-alpha RNA Virus Infections Anti-HIV Agents Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Zalcitabine Interferons Enzyme Inhibitors Angiogenesis Inhibitors Antiviral Agents |