Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC
Completed · Phase 2
Conditions studied: HIV Infections
In brief
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC. SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.
Key facts
- Study ID
- NCT00001040
- Run by
- Hoffmann-La Roche
- People needed
- 300
- Last updated by the study team
- 2011-03-01
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior Medication: Required:
- At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy.
- Patients must have:
- HIV seropositivity.
- Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
- CD4 count > 50 to <= 300 cells/mm3.
- Life expectancy of at least 6 months.
- Prior AZT therapy.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
- Known intolerance to Ro 31-8959, AZT, or ddC.
- Symptoms suggestive of pancreatitis.
- Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding.
- Visceral Kaposi's sarcoma.
- Lymphoma that will require therapy within the next 6 months.
- Transfusion dependence.
- Concurrent Medication:
- Excluded:
- Investigational or antineoplastic agents.
- Concurrent Treatment:
- Excluded:
- Radiotherapy (other than local skin radiotherapy).
- Transfusions.
- Prior Medication:
- Excluded:
- Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry.
- Prior treatment with an HIV proteinase inhibitor.
Where it is running
- Univ of Alabama at Birmingham — Birmingham, Alabama, United States
- Stanford Univ Med Ctr — Stanford, California, United States
- Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
- Northwestern Univ Med School — Chicago, Illinois, United States
- Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
- Univ of Rochester Med Ctr — Rochester, New York, United States
- Ohio State Univ Hosp — Columbus, Ohio, United States
- Girard Med Ctr — Philadelphia, Pennsylvania, United States
- Univ TX Galveston Med Branch — Galveston, Texas, United States
- Univ of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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