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
NCT ID: NCT00002334
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3000 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Saquinavir
Zidovudine
Zalcitabine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Locations
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Phoenix Body Positive
Phoenix, Arizona, United States
UCD Med Ctr
Sacramento, California, United States
Davies Med Ctr
San Francisco, California, United States
Mount Zion Med Ctr / UCSF
San Francisco, California, United States
Pacific Oaks Med Group
Sherman Oaks, California, United States
Sunnyvale Med Clinic
Sunnyvale, California, United States
Novum Inc
Washington D.C., District of Columbia, United States
Howard Univ
Washington D.C., District of Columbia, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
Massachusetts Gen Hosp
Boston, Massachusetts, United States
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, United States
Beth Israel Med Ctr
New York, New York, United States
Harkness Pavilion
New York, New York, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States
Univ of Oklahoma Health Science / Pharmacy Practice
Oklahoma City, Oklahoma, United States
Novum Inc
Pittsburgh, Pennsylvania, United States
Respiratory Associates
Corpus Christi, Texas, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, United States
Univ of Washington
Seattle, Washington, United States
San Juan Veterans Administration Med Ctr
San Juan, , Puerto Rico
Countries
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References
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Collier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60
Other Identifiers
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SV 14604C
Identifier Type: -
Identifier Source: secondary_id
SV 14604A
Identifier Type: -
Identifier Source: secondary_id
229B
Identifier Type: -
Identifier Source: org_study_id