Completed

Safety and Tolerability of Dideoxycytidine (ddC) in AIDS or Advanced ARC Patients Intolerant to Zidovudine (AZT)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Zalcitabine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+56 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

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

This study focuses on evaluating the safety and tolerability of a drug called dideoxycytidine (ddC) in individuals with AIDS or advanced AIDS-related complex (ARC). These individuals previously showed intolerance to another drug, zidovudine (AZT), during their participation in Protocol N3300 or N3492. The goal is to determine if ddC can be a suitable alternative for those who cannot tolerate AZT. This research is important as it aims to find better treatment options for patients with AIDS or ARC, addressing the need for alternatives when certain medications cause adverse reactions.

NCT00002265
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 13 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

28 inclusion criteria required to participate
Acyclovir ( = or < 1000 mg/day)
After permanent study drug discontinuation from NIAID ACTG 114 the drug code may be broken ONLY after discussion with Hoffmann-La Roche regarding toxicity management and probable relationship to AZT. Although NIAID ACTG 119 is an open-label study, investigators should also contact Hoffmann-La Roche prior to entering any patient into this protocol
Allowed
Allowed for maintenance after recovering from infection for which initially prescribed
Show More Criteria
28 exclusion criteria prevent from participating
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
Active substance or alcohol abuse
An active AIDS defining opportunistic infection or other active intercurrent illnesses if their ongoing treatment requires the use of excluded medications (see Exclusion - Concurrent Medications)
Show More Criteria

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 9 locations

Davies Med Ctr

San Francisco, United StatesOpen Davies Med Ctr in Google Maps

Mount Zion Med Ctr

San Francisco, United States

Ctr for Special Immunology

Fort Lauderdale, United States

Dr Robert Swartz

Fort Myers, United States
Completed9 Study Centers