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A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment Clinical research trials and A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment. A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment
A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
Details: Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Erythropoietin and G-CSF. Concurrent Treatment: Allowed: - Local skin radiotherapy. Patients must have: - HIV infection. - CD4 count 50 - 350 cells/mm3. - No prior antiretroviral therapy OR less than 16 weeks of prior AZT. - No acute serious opportunistic infections requiring immediate treatment. - No unexplained fever persisting for 14 days within 90 days prior to study entry. - No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. - No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. - Life expectancy of at least 80 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malabsorption. - Severe chronic diarrhea. - Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). - Any grade 3 or worse toxicity. - Inability to comply with study requirements. Concurrent Medication: Excluded: - Other investigational agents. - Antineoplastic agents. - Biologic response modifiers (including interferons). - Foscarnet. - Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded: - Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded: - Acute therapy for opportunistic infection within 14 days prior to study entry. - Prior HIV proteinase inhibitor.
Total Enrollment: 3000
Location and Contact Information:
Univ of Washington
Seattle, Washington, 981224379
United States
UCD Med Ctr
Sacramento, California, 95817
United States
Harkness Pavilion
New York City, New York, 10032
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, 77009
United States
Howard Univ
Washington D.C., District of Columbia, 20060
United States
Univ of Oklahoma Health Science / Pharmacy Practice
Oklahoma City, Oklahoma, 73117
United States
Novum Inc
Pittsburgh, Pennsylvania, 152063817
United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
United States
San Juan Veterans Administration Med Ctr
San Juan, , 009275800
Puerto Rico
Beth Israel Med Ctr
New York City, New York, 10003
United States
Phoenix Body Positive
Phoenix, Arizona, 85016
United States
Sunnyvale Med Clinic
Sunnyvale, California, 94086
United States
Novum Inc
Washington D.C., District of Columbia, 20037
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Respiratory Associates
Corpus Christi, Texas, 78404
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403
United States
Additional Information:
Study ID Numbers: 229B; SV 14604C,SV 14604A
Study Start Date:
Record last reviewed: September 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002334
Other Hiv Infections Studies:
1. Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
2. Quality of Life in Children with HIV Infection
3. A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
4. Fuzeon (Enfuvirtide) Early Access Program for Patients with HIV-1 Infection
5. Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment
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