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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like 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. 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 Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Participants frequently obtain the most expert healthcare available for their 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 condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 256
Location and Contact Information:
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
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
ViRx Inc
San Francisco, California, 94103
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Univ of South Florida
Tampa, Florida, 33612
United States
Stratogen of South Florida
Miami, Florida, 33140
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
Vanderbilt School of Medicine
Nashville, Tennessee, 37232
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670560
United States
Marin County Specialty Clinic
San Rafael, California, 94903
United States
Additional Information:
Study ID Numbers: 052C; 03
Study Start Date:
Record last reviewed: October 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002086
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3. Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex
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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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