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A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection Clinical research trials and A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection. A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection clinical trial. Participants frequently get the best healthcare available for their A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection  A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration. The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Details: The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity. Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks. PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-1 seropositivity. - CD4 count >= 550 cells/mm3. - Asymptomatic disease. - No prior antiretroviral therapy. - Consent of parent or guardian if less than 18 years old. PER AMENDMENT 6/18/96: - Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Medical condition that precludes study compliance. Concurrent Medication: Excluded: - Antiretrovirals other than study drugs. - Biologic response modifiers including erythropoietin and G-CSF. - Systemic corticosteroids. - Systemic cytotoxic chemotherapy. - Intravenous pentamidine. Concurrent Treatment: Excluded: - Systemic radiation therapy. Patients with the following prior conditions are excluded: - History of grade 2 or worse peripheral neuropathy. - History of pancreatitis or factors predisposing to pancreatitis. Prior Medication: Excluded: - Prior antiretrovirals. - Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry. Chronic alcoholism.
Total Enrollment: 85
Location and Contact Information:
Overall Study Official:
CollierAC, Study Chair,
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Additional Information:
Study ID Numbers: ACTG 276;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000823
Other Hiv Infections Studies:
1. A Study to Evaluate the Ability of TNFR:Fc to Decrease the Amount of IL-6 (Interleukin-6) and TNF-alpha (Tumor Necrosis Factor) in HIV-Infected Patients
2. The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection
3. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
4. A Study of HIV in Newly Infected Individuals
5. A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
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