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.
2 other identifiers
interventional
320
1 country
10
Brief Summary
To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have already received at least 1 year of AZT therapy and to define the safety profile. ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
July 1, 1992
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 14, 2011
September 1, 1992
November 2, 1999
March 11, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Davies Med Ctr
San Francisco, California, 94114, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219, United States
Related Publications (2)
Fischl MA, Olson RM, Follansbee SE, Lalezari JP, Henry DH, Frame PT, Remick SC, Salgo MP, Lin AH, Nauss-Karol C, Lieberman J, Soo W. Zalcitabine compared with zidovudine in patients with advanced HIV-1 infection who received previous zidovudine therapy. Ann Intern Med. 1993 May 15;118(10):762-9. doi: 10.7326/0003-4819-118-10-199305150-00002.
PMID: 8097082BACKGROUNDGries JM, Troconiz IF, Verotta D, Jacobson M, Sheiner LB. A pooled analysis of CD4 response to zidovudine and zalcitabine treatment in patients with AIDS and AIDS-related complex. Clin Pharmacol Ther. 1997 Jan;61(1):70-82. doi: 10.1016/S0009-9236(97)90183-1.
PMID: 9024175BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
July 1, 1992
Last Updated
March 14, 2011
Record last verified: 1992-09