Completed
Dideoxycytidine (ddC) Monotherapy for AIDS or Advanced ARC Patients Intolerant to Zidovudine (AZT)
What is being tested
Zalcitabine
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Over 12 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on a treatment called zalcitabine (ddC) for patients diagnosed with AIDS or advanced ARC (AIDS-Related Complex). The study is designed for those who cannot use zidovudine (AZT) due to its contraindications, or those who have not responded well to AZT treatment in the past, or find it hard to tolerate. The main goal of this research is to explore if ddC can be a safe and well-tolerated treatment option for this specific group of patients, potentially addressing a significant unmet need in AIDS and ARC care.
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
12 inclusion criteria required to participate
Dapsone is permitted but discouraged.
The following experimental medications are allowed if, in the judgement of the investigator, no serious additive toxicities are anticipated and the experimental drug is necessary for optimal patient management: Ampligen, azithromycin, BW 566C80, bovine colostrum, clarithromycin, diclazuril, foscarnet, oral ganciclovir, GM-CSF, G-CSF, hypericin, IL-2, interferon-beta, interferon-gamma, itraconazole, liposomal amphotericin, liposomal gentamicin, nimodipine, PEG-IL2 (polyethylene glycosylated IL-2), roxithromycin, spiramycin, trimetrexate.
Drugs that could cause other serious toxicity when coadministered with study medication is allowed for treatment of an acute intercurrent illness or opportunistic infection at the investigator's discretion.
Metronidazole is permitted only with a study drug interruption.
Show More Criteria
4 exclusion criteria prevent from participating
Concomitant treatment with excluded medications. Excluded medications include any other experimental drugs (including ddI), drugs with known nephrotoxic or hepatotoxic potential, and drugs likely to cause peripheral neuropathy. Any = or > Grade 3 laboratory or clinical abnormality or any severe abnormality not listed requires permission from the medical monitor to be entered into this study.
Any history of peripheral neuropathy due to any cause, even if peripheral neuropathy was not the reason for discontinuation of other anti-HIV therapy.
Unwillingness or deemed unable to sign informed consent.
Any finding suggestive of peripheral neuropathy found at baseline neurological exam. If a 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.
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
CompletedOne Study Center