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 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
3 other identifiers
interventional
3,000
2 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
September 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
UCD Med Ctr
Sacramento, California, 95817, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115, United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403, United States
Sunnyvale Med Clinic
Sunnyvale, California, 94086, United States
Novum Inc
Washington D.C., District of Columbia, 20037, United States
Howard Univ
Washington D.C., District of Columbia, 20060, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699, United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114, United States
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Harkness Pavilion
New York, New York, 10032, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Univ of Oklahoma Health Science / Pharmacy Practice
Oklahoma City, Oklahoma, 73117, United States
Novum Inc
Pittsburgh, Pennsylvania, 152063817, United States
Respiratory Associates
Corpus Christi, Texas, 78404, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219, United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882, United States
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, 77009, United States
Univ of Washington
Seattle, Washington, 981224379, United States
San Juan Veterans Administration Med Ctr
San Juan, 009275800, Puerto Rico
Related Publications (1)
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
BACKGROUND