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Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

This study has been completed.
Study NCT00001040.   Last updated on August 22, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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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.

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
MEDLINE PMIDs 9841849,   8721557,   8799687,   9371346,   8598838,   7985892
Links Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site
Click here for more information about Saquinavir This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  300
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

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.

Exclusion Criteria

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.
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 
Study Chair:     Collier AC        
Study Chair:     Corey L        
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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