Search / Trial NCT00001040

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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Apply for Trial

Trial Information

Current as of March 02, 2024

Completed

Keywords

Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Saquinavir Hiv Protease Inhibitors

Description

No description provided

Gender

All

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.

Attachments

readout_NCT00001040_2024-03-02.pdf

4.5 MB

NCT00001040_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

Chicago, Illinois, United States

Seattle, Washington, United States

New York, New York, United States

Stanford, California, United States

Philadelphia, Pennsylvania, United States

Denver, Colorado, United States

Galveston, Texas, United States

Rochester, New York, United States

Columbus, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0