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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Zidovudine (Drug); Zalcitabine (Drug); Interferon alfa-n1 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Glaxo Wellcome
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Safety Study
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
ViRx Inc, San Francisco, California 94103, United States
Marin County Specialty Clinic, San Rafael, California 94903, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
Univ of South Florida, Tampa, Florida 33612, United States
Stratogen of South Florida, Miami Beach, Florida 33140, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States
North Shore Univ Hosp / Div of Infectious Diseases, Manhasset, New York 11030, United States
Univ of Cincinnati, Cincinnati, Ohio 452670560, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States
Vanderbilt School of Medicine, Nashville, Tennessee 37232, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Univ of Utah School of Medicine, Salt Lake City, Utah 84132, United States
Additional Information
Related publications: 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
Last updated: June 23, 2005
|
