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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002334

Run by

Hoffmann-La Roche

People needed

3000

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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