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
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ClinicalTrials.gov Identifier: NCT00002086 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Zidovudine Drug: Zalcitabine Drug: Interferon alfa-n1 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 256 participants |
Allocation: | Randomized |
Primary Purpose: | Treatment |
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 |


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Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- HIV infection documented by licensed ELISA confirmed by Western blot; OR positive HIV culture; OR positive HIV antigen; OR plasma viremia.
- CD4 counts >= 300 and <= 500 cells/mm3 on two occasions within 30 days prior to study entry.
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:
- Current AIDS-defining indicator disease, including opportunistic infections, AIDS dementia, AIDS-wasting syndrome, and AIDS-associated malignancy.
- Grade 2 or worse peripheral neuropathy.
- Intolerance to Retrovir at 600 mg/day, HIVID at 2.25 mg/day, or any interferon-alfa product at 3.0 MU/day.
- Significant cardiac dysfunction (NYHA grade 3 or 4).
Concurrent Medication:
Excluded:
- Chemotherapeutic agents during the 76 weeks following study entry.
- Cardiac glycosides, antiarrhythmics, or vasodilators.
Patients with the following prior conditions are excluded:
- History of AIDS-defining indicator disease, including opportunistic infections, AIDS dementia, AIDS-wasting syndrome, or AIDS-associated malignancy.
- History of grade 2 or worse peripheral neuropathy.
- History of intolerance to Retrovir at 600 mg/day, HIVID at 2.25 mg/day, or any interferon-alfa product at 3.0 MU/day.
Prior Medication:
Excluded:
- More than 3 months of any prior antiretroviral therapy.
- Cytotoxic chemotherapy within 4 weeks prior to study entry.
- Immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alfa, or IFN-beta within 4 weeks prior to study entry.
- Cardiac glycosides, antiarrhythmics, or vasodilators.
Prior Treatment:
Excluded:
- Radiation therapy within 4 weeks prior to study entry. Current alcohol or illicit drug use that would interfere with patient compliance.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002086
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 | |
Stratogen of South Florida | |
Miami Beach, Florida, United States, 33140 | |
Univ of South Florida | |
Tampa, Florida, United States, 33612 | |
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 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002086 History of Changes |
Other Study ID Numbers: |
052C 03 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | October 1993 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Zalcitabine Drug Therapy, Combination AIDS-Related Complex Zidovudine Interferon-alpha |
Additional relevant MeSH terms:
Infection Communicable Diseases 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 Interferons Interferon-alpha |
Zidovudine Zalcitabine Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Anti-HIV Agents |