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 - Article ddC; dideoxycytidine; Hivid
Clinical Trial: 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
This study has been completed.
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.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Saquinavir |
|Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
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
Expected Total Enrollment: 3000
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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.
Co-existing Condition: Patients with the following symptoms or conditions are excluded:
- 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).
- 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.
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
District of Columbia
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
San Juan Veterans Administration Med Ctr, San Juan, 009275800, Puerto Rico
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
Record last reviewed: September 1996
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002334
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005