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
NCT ID: NCT00002086
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
256 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Zidovudine
Zalcitabine
Interferon alfa-n1
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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ViRx Inc
San Francisco, California, United States
Marin County Specialty Clinic
San Rafael, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Stratogen of South Florida
Miami Beach, Florida, United States
Univ of South Florida
Tampa, Florida, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Vanderbilt School of Medicine
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, United States
Countries
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References
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Lavelle J, Haas D, Barry D, Mustafa N, Mciunnis R, Rooney J. Long-term safety and efficacy of initial triple combination therapy with ZDV, ddC and interferon alpha-n1 vs. ZDV and ddC in patients with CD4+ cell counts 300-500 cells/mm3. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:107
Other Identifiers
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03
Identifier Type: -
Identifier Source: secondary_id
052C
Identifier Type: -
Identifier Source: org_study_id