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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 Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about 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 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms 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 allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally 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. Subjects frequently get the best healthcare possible 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. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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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
Other Hiv Infections Studies:
1. A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
2. T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
3. A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
4. A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
5. The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
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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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