An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492
2 other identifiers
interventional
N/A
1 country
9
Brief Summary
To demonstrate that zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable in the treatment of patients with AIDS or advanced AIDS related complex (ARC) who previously demonstrated intolerance to zidovudine (AZT) treatment while in Protocol N3300 (NIAID ACTG 114) or N3492 (NIAID ACTG 119). NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY: Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir or oral acyclovir or other bone marrow or renal toxic drugs may not tolerate concomitant ddC. If these drugs are given concomitantly with ddC, patients should have frequent clinical and laboratory assessments, as appropriate. Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy might be expected to cause increased toxicity when co-administered with ddC. Drugs that could cause serious additive toxicity when co-administered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator. Their use may be allowed with interruption of study drug for up to 35 days per episode, for a total of 90 days for the study. If the patient's condition requires chronic administration of these medications, the patient will be discontinued from study medication and followed.
Trial Health
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9 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1994
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Recommended:
- Prophylactic aerosolized pentamidine.
- Allowed for maintenance after recovering from infection for which initially prescribed:
- Pyrimethamine.
- Sulfadiazine.
- Amphotericin.
- Fluconazole.
- Ketoconazole (= or \< 400 mg/day).
- Acyclovir ( = or \< 1000 mg/day).
- Ganciclovir.
- Medications for tuberculosis or Mycobacterium avium infection.
- Allowed:
- Erythropoietin.
- Megace.
- +15 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Baseline fever \> 38.5 C if caused by an occult opportunistic infection or neoplasm and requiring continuous treatment with excluded medications. If the evaluation for infection is unrevealing, the patient may be entered after the evaluation is completed but while mycobacterial cultures are still pending. Patients with a history of unexplained fever \> 38.5 C should be evaluated as above and/or be afebrile (T \< 38.0 C) for 2 weeks prior to study entry.
- Severe AIDS dementia complex as defined by a score of \< 23 on the Mini-Mental State Exam at the time of discontinuation from NIAID ACTG 114 or NIAID ACTG 119.
- Any history of peripheral neuropathy or moderate to severe peripheral neuropathy as defined below:
- A score of = or \> 4 in any one category or a score of = or \> 2 in two categories of the peripheral neuropathy segment of the Signs and Symptoms Questionnaire.
- Accompanied by:
- Results on the Standardized Neurological exam indicative of a moderate abnormality, particularly impaired sensation of sharp pain, light touch or vibration in lower extremities, distal extremity weakness or distal extremity hyporeflexia.
- Significant cardiac disease, defined as history of ventricular arrhythmias requiring medication, prior myocardial infarct or history of angina or ischemia changes on EKG.
- Significant liver disease, as defined by transaminases \> 5 x upper limit of normal or a history of cirrhosis or ascites.
- Significant renal disease as defined by an estimated creatinine clearance \< 50 ml/min.
- Concurrent Medication:
- Excluded:
- Other antiretroviral agents.
- Biologic modifiers.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Davies Med Ctr
San Francisco, California, 94114, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, 33308, United States
Dr Robert Swartz
Fort Myers, Florida, 33901, United States
Med Service
Miami, Florida, 33125, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146, United States
Humana Hosp / Med City Dallas
Dallas, Texas, 75230, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1994-02