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
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: September 1996
History of Changes
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.
Drug : Saquinavir
Drug : Zidovudine
Drug : Zalcitabine
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Erythropoietin and G-CSF.
- Local skin radiotherapy.
- 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.
- 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.
- Other investigational agents.
- Antineoplastic agents.
- Biologic response modifiers (including interferons).
- Anti-HIV drugs other than the study drugs.
- Radiotherapy (other than local skin radiotherapy).
- Acute therapy for opportunistic infection within 14 days prior to study entry.
- Prior HIV proteinase inhibitor.
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded:
History of non-Hodgkin's lymphoma.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002334
Locations Show More
|United States, Arizona|
|Phoenix Body Positive|
|Phoenix, Arizona, United States, 85016|
|United States, California|
|UCD Med Ctr|
|Sacramento, California, United States, 95817|
|Davies Med Ctr|
|San Francisco, California, United States, 94114|
|Mount Zion Med Ctr / UCSF|
|San Francisco, California, United States, 94115|
|Pacific Oaks Med Group|
|Sherman Oaks, California, United States, 91403|
|Sunnyvale Med Clinic|
|Sunnyvale, California, United States, 94086|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20037|
|Washington, District of Columbia, United States, 20060|
|United States, Florida|
|Miami Veterans Administration Med Ctr|
|Miami, Florida, United States, 33125|
|Univ of Miami School of Medicine|
|Miami, Florida, United States, 331361013|
|United States, Illinois|
|Cook County Hosp|
|Chicago, Illinois, United States, 60612|
|Rush Presbyterian - Saint Luke's Med Ctr|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|Tulane Univ Med School|
|New Orleans, Louisiana, United States, 701122699|
|United States, Massachusetts|
|Massachusetts Gen Hosp|
|Boston, Massachusetts, United States, 02114|
|United States, Nevada|
|HIV Wellness Ctr / Univ Med Ctr|
|Las Vegas, Nevada, United States, 89102|
|United States, New York|
|Beth Israel Med Ctr|
|New York, New York, United States, 10003|
|New York, New York, United States, 10032|
|United States, Ohio|
|Univ Hosp of Cleveland / Case Western Reserve Univ|
|Cleveland, Ohio, United States, 44106|
|United States, Oklahoma|
|Univ of Oklahoma Health Science / Pharmacy Practice|
|Oklahoma City, Oklahoma, United States, 73117|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 152063817|
|United States, Texas|
|Corpus Christi, Texas, United States, 78404|
|N Texas Ctr for AIDS & Clin Rsch|
|Dallas, Texas, United States, 75219|
|Univ TX Galveston Med Branch|
|Galveston, Texas, United States, 775550882|
|Thomas Street Clinic / Baylor College of Medicine|
|Houston, Texas, United States, 77009|
|United States, Washington|
|Univ of Washington|
|Seattle, Washington, United States, 981224379|
|San Juan Veterans Administration Med Ctr|
|San Juan, Puerto Rico, 009275800|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002334 History of Changes|
|Other Study ID Numbers:||229B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.