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| Descriptive Information Fields | |||||||||
| Brief Title † | Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC | ||||||||
| Official Title † | Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC | ||||||||
| Brief Summary | 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | Drug: Saquinavir Drug: Zidovudine Drug: Zalcitabine |
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| MEDLINE PMIDs | 9841849, 8721557, 8799687, 9371346, 8598838, 7985892 | ||||||||
| Links | Click here for more information about Zidovudine ![]() Click here for more information about Saquinavir  ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 300 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria Prior Medication: Required:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Prior Medication: Excluded:
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| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00001040 | ||||||||
| Organization ID | ACTG 229 | ||||||||
| Secondary IDs †† | NV14255D, FDA 123A | ||||||||
| Study Sponsor † | Hoffmann-La Roche | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | February 1995 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | August 22, 2008 | ||||||||