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.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001040
First received: November 2, 1999
Last updated: February 28, 2011
Last verified: February 2011

November 2, 1999
February 28, 2011
Not Provided
May 1994   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00001040 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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

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.

Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
HIV Infections
  • Drug: Saquinavir
  • Drug: Zidovudine
  • Drug: Zalcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Not Provided
May 1994   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001040
ACTG 229, NV14255D, FDA 123A
Not Provided
Not Provided
Hoffmann-La Roche
Not Provided
Study Chair: Collier AC
Study Chair: Corey L
National Institute of Allergy and Infectious Diseases (NIAID)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP