Search / Trial NCT00002081

Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Zalcitabine Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

ClinConnect Summary

Patients are treated with 1 of 2 doses of ddC administered orally (PO) in combination with AZT administered PO (patients who are unable to tolerate this dose of AZT may receive a lower dose).

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Concomitant use of investigational compounds for prophylaxis or treatment of opportunistic infections or other treatments provided use of those compounds with ddC-AZT is considered safe.
  • Patients must have:
  • Documented HIV infection OR documented AIDS-defining opportunistic infection or neoplasm.
  • Previous AIDS-defining opportunistic infection, neoplasm, or condition OR CD4 lymphocyte count equal to or less than 300 cells/mm3 if symptomatic ORCD4 lymphocyte count equal to or less than 200 cells/mm3 if asymptomatic.
  • Patients must not be currently enrolled in or must be unable to enter an AIDS Clinical Trials Group (ACTG), Community Programs for Clinical Research on AIDS (CPCRA), or other controlled clinical program because of patient ineligibility, distance from trial site, or patient refusal.
  • Patients currently enrolled in any controlled clinical trial of an anti-HIV compound may enter this program only if they have met the end points required for termination of that trial.
  • Patients may be co-enrolled in clinical programs of investigational compounds being tested for prophylaxis or treatment of opportunistic infections or other treatments provided that program allows ddC-AZT combination use, and concomitant administration of the other investigational drug and ddC-AZT is considered safe by the investigator.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Any clinical or laboratory toxicity or abnormality, particularly the presence or history of moderate to severe peripheral neuropathy, that would pose an undue risk to the patient upon initiation of ddC-AZT treatment.
  • Pregnancy.

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Wellesley Hills, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials