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HIV InfectionsPhase 2NCT00002265

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

A Phase 2 study testing Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zalcitabine
How many people
Not given
Where
9 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Recommended:
  • Prophylactic aerosolized pentamidine.
  • Allowed for maintenance after recovering from infection for which initially prescribed:
  • Pyrimethamine.
  • Sulfadiazine.
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  • Amphotericin.
  • Fluconazole.
  • Ketoconazole (= or < 400 mg/day).
  • Acyclovir ( = or < 1000 mg/day).
  • Ganciclovir.
  • Medications for tuberculosis or Mycobacterium avium infection.
  • Allowed:
  • Erythropoietin.
  • Megace.
  • Trimethoprim/sulfamethoxazole < or = 20 mg/kg/day.
  • Nystatin.
  • Low dose acetaminophen or non-steroidal anti-inflammatory agents ( = or < 3 g/day).
  • Medications on which patient has been stable for 14 days prior to study entry.
  • Allowed if no evidence of peripheral neuropathy at study entry:
  • Isoniazid (must be receiving pyridoxine = or > 50 mg/day concomitantly).
  • Phenytoin, if stable for = or > 3 months.
  • Metronidazole with a study medication interruption and pre and post testing for peripheral neuropathy. Any signs of this and the patient will not be restarted on study medication.
  • REFER TO NOTE OF CAUTION IN PROTOCOL SUMMARY.
  • Patients must have the following:
  • Previously enrolled in NIAID ACTG 114 or NIAID ACTG 119.
  • Experienced = or > grade 3 zidovudine (AZT) related toxicity while enrolled in the assigned protocol and followed the procedures for the study drug dose reduction, interruption, rechallenge and permanent discontinuation as per NIAID ACTG 114 or NIAID ACTG 119.
  • NOTE:
  • 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.
  • Toxicities must be "probably" AZT related (as determined by the investigator and following discussion by sponsor) for patients to be eligible for inclusion into this protocol.
  • Toxicities must be resolved to = or < grade 2 within 45 days of discontinuation from AZT in NIAID ACTG 114 or NIAID ACTG 119.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • 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).
  • 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:
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  • 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.
  • Corticosteroids.
  • Other experimental agents including:
  • Foscarnet.
  • Ribavirin.
  • ddI.
  • Drugs that could cause peripheral neuropathy including:
  • Hydralazine.
  • Nitrofurantoin.
  • Vincristine.
  • Cisplatin.
  • Dapsone.
  • Disulfiram.
  • Diethyldithiocarbamate.
  • Patients with the following are excluded:
  • 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). Such patients will be allowed into the study if they have completed therapy with an excluded concomitant medication and are stable for 14 days. Had to discontinue study medication in NIAID ACTG 114 or NIAID ACTG 119 because of an opportunistic infection or intercurrent illness which required continuous treatment with medications allowed for concomitant administration in NIAID ACTG 114 or ACTG 119. Symptoms and conditions defined in patient Exclusion - Co-Existing Condition. Active substance or alcohol abuse. Unwillingness or deemed unable to sign informed consent.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Radiation therapy.
  • Active substance or alcohol abuse.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Humana Hosp / Med City Dallas

    Dallas, Texas, 75230

  • Henry Ford Hosp

    Detroit, Michigan, 48202

  • Ctr for Special Immunology

    Fort Lauderdale, Florida, 33308

  • Dr Robert Swartz

    Fort Myers, Florida, 33901

  • Med Service

    Miami, Florida, 33125

  • Graduate Hosp

    Philadelphia, Pennsylvania, 19146

  • Davies Med Ctr

    San Francisco, California, 94114

  • Mount Zion Med Ctr

    San Francisco, California, 94115

Other trials in United States

About this study

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.

Conditions
HIV Infections
Being tested
Zalcitabine
Keywords
Zalcitabine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZalcitabineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002265
Sponsor's protocol ID
031C
Other IDs
N3526A
Status last verified
Feb 1994
First submitted
2 Nov 1999
Last updated
24 Jun 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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Clinical Trial NCT00002265 | AzTrials