Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000678
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.
• Scientific title: Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.
• Date of first enrolment: July 2000
• Target sample size: 320
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000678
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria

Concurrent Medication:

Required:

- Aerosolized pentamidine will be given, as tolerated for all patients, for
Pneumocystis carinii pneumonia prophylaxis at a dose of 300 mg once every 4 weeks.

Allowed maintenance treatment with:

- Pyrimethamine (= or < 75 mg/day).

- Sulfadiazine (< 4 gl/day).

- Amphotericin (1 mg/kg/day up to 5 days).

- Fluconazole (400 mg/day).

- Ketoconazole (400 mg/day).

- Acyclovir (up to 12.4 mg/kg q8h IV for zoster or up to 4000 mg/day will be allowed PO
with precautions - nausea and vomiting possible with doses > 1000 mg/day).

- Ganciclovir (6 mg/kg/day).

- Medications for tuberculosis or Mycobacterium avium for patients who have recovered
from toxoplasmosis, cryptococcosis, candidiasis, herpes virus infections,
cytomegalovirus infections, tuberculosis, or Mycobacterium avium intracellulare.

- Erythropoietin and megace as needed.

- Isoniazid if patient has no peripheral neuropathy at study entry and is taking
pyridoxine at least 50 mg/day concomitantly.

- Phenytoin if patient has no peripheral neuropathy at study entry and has been stable
on the drug for at least 3 months.

Patients must have had Pneumocystis carinii pneumonia (PCP) and no other AIDS defining
opportunistic infection present when zidovudine (AZT) therapy was first initiated.

Patients must have:

- Advanced AIDS related complex (ARC).

- Antibody to HIV by federally licensed ELISA and confirmed by Western blot analysis.

- Ability to give conformed consent.

Exclusion Criteria

Co-existing Condition:

Patients are excluded who:

- Have had zidovudine (AZT) therapy interrupted for > 30 consecutive days at any time
during AZT therapy or have been off AZT for > 90 days total.

- Have had AZT therapy interrupted for "recurrent" grade 4 toxicity, defined as > one
episode of the same grade 4 toxicity after dose interruption or attenuation.

- Have visceral or extensive Kaposi's sarcoma requiring therapy or any other malignancy
requiring therapy.

- Have a history of peripheral neuropathy.

Concurrent Medication:

Excluded:

- Other experimental medications, including foscarnet, ribavirin, and fluconazole
(prior to IND approval).

- Other antiretroviral agents, biologic modifiers or corticosteroids.

- Drugs that can cause peripheral neuropathy including phenytoin (under conditions not
specifically allowed), hydralazine, metronidazole, nitrofurantoin, vincristine,
cisplatinum, dapsone, disulfiram, and diethyldithiocarbamate.

Patients with the following are excluded:

- History of peripheral neuropathy or moderate to severe peripheral neuropathy as
defined by the combination of signs or symptoms of peripheral neuropathy and findings
indicative of peripheral neuropathy on the standardized neurologic exam.

- Active opportunistic infection.

- Participation in another research treatment study.

Prior Medication:

Excluded:

- Dideoxycytidine (ddC).

- Didanosine (ddI).

Active substance or alcohol abuse.



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Zalcitabine

Drug: Zidovudine

Secondary ID(s)

ACTG 119

N3492B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche