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Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zalcitabine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Aerosolized Pentamidine or Trimethoprim/sulfamethoxazole prophylaxis against Pneumocystis carinii pneumonia is recommended. Dapsone is permitted but discouraged. 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. Any medication that has the potential to cause peripheral neuropathy should be avoided; patients should consult their physicians for specific drugs. Isoniazid is permitted if there is no evidence of peripheral neuropathy at entry and the patient is taking pyridoxine = or > 50 mg/day. Metronidazole is permitted only with a study drug interruption. Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir = or > 1000 mg/day orally 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 (weekly) 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. 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. Patients must have the following: AIDS or Advanced ARC. Patients eligible to enter this protocol must fall into one of the following three categories: AZT treatment failure or AZT intolerance or AZT ineligibility or Rollover Patients Under 18 years of age must have the consent of a parent or guardian. Exclusion Criteria Patients with the following are excluded: Any history of peripheral neuropathy due to any cause, even if peripheral neuropathy was not the reason for discontinuation of other anti-HIV therapy. 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. 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.. Unwillingness or deemed unable to sign informed consent.

Sites / Locations

  • Hoffmann - La Roche Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002256
Brief Title
Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.
Official Title
Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
To provide zalcitabine ( ddC ) for patients with AIDS or Advanced ARC in whom zidovudine ( AZT ) is contraindicated, or who have failed treatment with or are intolerant to AZT and to demonstrate that ddC monotherapy is safe, and tolerable in this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zalcitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Aerosolized Pentamidine or Trimethoprim/sulfamethoxazole prophylaxis against Pneumocystis carinii pneumonia is recommended. Dapsone is permitted but discouraged. 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. Any medication that has the potential to cause peripheral neuropathy should be avoided; patients should consult their physicians for specific drugs. Isoniazid is permitted if there is no evidence of peripheral neuropathy at entry and the patient is taking pyridoxine = or > 50 mg/day. Metronidazole is permitted only with a study drug interruption. Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir = or > 1000 mg/day orally 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 (weekly) 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. 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. Patients must have the following: AIDS or Advanced ARC. Patients eligible to enter this protocol must fall into one of the following three categories: AZT treatment failure or AZT intolerance or AZT ineligibility or Rollover Patients Under 18 years of age must have the consent of a parent or guardian. Exclusion Criteria Patients with the following are excluded: Any history of peripheral neuropathy due to any cause, even if peripheral neuropathy was not the reason for discontinuation of other anti-HIV therapy. 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. 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.. Unwillingness or deemed unable to sign informed consent.
Facility Information:
Facility Name
Hoffmann - La Roche Inc
City
Nutley
State/Province
New Jersey
ZIP/Postal Code
071101199
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.

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