Completed

Dideoxycytidine (ddC) Safety Study in AIDS or Advanced ARC Patients Intolerant to Zidovudine (AZT) Therapy

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What is being tested

Zalcitabine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

The first 50 patients enrolled into the study will be with investigators having prior ddC experience, specifically AIDS Clinical Trials Group (ACTG), or non-ACTG investigators who are listed in ddC protocols NIAID ACTG 012, 112, 047, 050, 106 (N3447), 114 (N3300), 119 (N3492), N3226, or investigators at any ACTG center or ACTG satellite centers with knowledge of ddC therapy. Once all 50 patients have been entered and 25 have completed four weeks of treatment the study will be dependent upon receipt of completed case forms up to week #4 of treatment for the 25 patients who have been reviewed and evaluated for safety. Patients 51-200 may then be entered by any physician licensed in his or her state who has experience with AIDS patients and agrees to follow the patients as specified in the protocol. After all 200 have been entered and week #16 case report forms are returned to the ddC Coordinating Center and reviewed for safety for 100 of the 200 patients, the protocol would be open without limit on numbers of patients.

NCT00002279
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

9 inclusion criteria required to participate
Aerosolized Pentamidine or other prophylaxis against Pneumocystis carinii pneumonia (PCP) is recommended
Drugs or treatments that could cause other serious additive toxicity when coadministered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator
If these drugs are given concomitantly with ddC, patients should have frequent (weekly) laboratory assessments, as appropriate
Isoniazid, if there is no evidence of peripheral neuropathy at entry and the patient is taking pyridoxine = or > 50 mg/day
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22 exclusion criteria prevent from participating
Any finding suggestive of peripheral neuropathy found at neurological exam. If patient has an isolated finding of an absent achilles reflex he may be entered if no signs or symptoms and no other findings are suggestive of peripheral neuropathy
Any history of peripheral neuropathy due to any cause, even if peripheral neuropathy was not the reason for discontinuation of other anti-HIV therapy
Chloramphenicol
Cisplatin
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hoffmann - La Roche Inc

Nutley, United StatesOpen Hoffmann - La Roche Inc in Google Maps
CompletedOne Study Center