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 source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Saquinavir (Drug); Zidovudine (Drug); Zalcitabine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hoffmann-La Roche
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.
Clinical Details
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
Study design: Treatment, Double-Blind, Safety Study
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
San Juan Veterans Administration Med Ctr, San Juan 009275800, Puerto Rico
Phoenix Body Positive, Phoenix, Arizona 85016, United States
UCD Med Ctr, Sacramento, California 95817, United States
Sunnyvale Med Clinic, Sunnyvale, California 94086, United States
Pacific Oaks Med Group, Sherman Oaks, California 91403, United States
Davies Med Ctr, San Francisco, California 94114, United States
Mount Zion Med Ctr / UCSF, San Francisco, California 94115, United States
Howard Univ, Washington, District of Columbia 20060, United States
Novum Inc, Washington, District of Columbia 20037, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Cook County Hosp, 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
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
Respiratory Associates, Corpus Christi, Texas 78404, United States
Univ of Washington, Seattle, Washington 981224379, United States
Additional Information
Related publications: 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
Last updated: June 23, 2005
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