AzTrials
AzTrials

HIV InfectionsPhase 2NCT00000678

Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.

A Phase 2 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have already received at least 1 year of AZT therapy and to define the safety profile. 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?
Zidovudine and Zalcitabine
How many people
320 participants
Where
10 sitesUnited States
Study dates
Start not givento Jul 1992
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:
  • Required:
  • Aerosolized pentamidine will be given, as tolerated for all patients, for Pneumocystis carinii pneumonia prophylaxis at a dose of 300 mg once every 4 weeks.
  • Allowed maintenance treatment with:
  • Pyrimethamine (= or < 75 mg/day).
  • Sulfadiazine (< 4 gl/day).
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  • Amphotericin (1 mg/kg/day up to 5 days).
  • Fluconazole (400 mg/day).
  • Ketoconazole (400 mg/day).
  • Acyclovir (up to 12.4 mg/kg q8h IV for zoster or up to 4000 mg/day will be allowed PO with precautions - nausea and vomiting possible with doses > 1000 mg/day).
  • Ganciclovir (6 mg/kg/day).
  • Medications for tuberculosis or Mycobacterium avium for patients who have recovered from toxoplasmosis, cryptococcosis, candidiasis, herpes virus infections, cytomegalovirus infections, tuberculosis, or Mycobacterium avium intracellulare.
  • Erythropoietin and megace as needed.
  • Isoniazid if patient has no peripheral neuropathy at study entry and is taking pyridoxine at least 50 mg/day concomitantly.
  • Phenytoin if patient has no peripheral neuropathy at study entry and has been stable on the drug for at least 3 months.
  • Patients must have had Pneumocystis carinii pneumonia (PCP) and no other AIDS defining opportunistic infection present when zidovudine (AZT) therapy was first initiated.
  • Patients must have:
  • Advanced AIDS related complex (ARC).
  • Antibody to HIV by federally licensed ELISA and confirmed by Western blot analysis.
  • Ability to give conformed consent.

Who cannot join

  • Co-existing Condition:
  • Patients are excluded who:
  • Have had zidovudine (AZT) therapy interrupted for > 30 consecutive days at any time during AZT therapy or have been off AZT for > 90 days total.
  • Have had AZT therapy interrupted for "recurrent" grade 4 toxicity, defined as > one episode of the same grade 4 toxicity after dose interruption or attenuation.
  • Have visceral or extensive Kaposi's sarcoma requiring therapy or any other malignancy requiring therapy.
  • Have a history of peripheral neuropathy.
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  • Concurrent Medication:
  • Excluded:
  • Other experimental medications, including foscarnet, ribavirin, and fluconazole (prior to IND approval).
  • Other antiretroviral agents, biologic modifiers or corticosteroids.
  • Drugs that can cause peripheral neuropathy including phenytoin (under conditions not specifically allowed), hydralazine, metronidazole, nitrofurantoin, vincristine, cisplatinum, dapsone, disulfiram, and diethyldithiocarbamate.
  • Patients with the following are excluded:
  • History of peripheral neuropathy or moderate to severe peripheral neuropathy as defined by the combination of signs or symptoms of peripheral neuropathy and findings indicative of peripheral neuropathy on the standardized neurologic exam.
  • Active opportunistic infection.
  • Participation in another research treatment study.
  • Prior Medication:
  • Excluded:
  • Dideoxycytidine (ddC).
  • Didanosine (ddI).
  • Active substance or alcohol abuse.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Albany Med College / AIDS Treatment Ctr

    Albany, New York, 12203

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Holmes Hosp / Univ of Cincinnati Med Ctr

    Cincinnati, Ohio, 452670405

  • N Texas Ctr for AIDS & Clin Rsch

    Dallas, Texas, 75219

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Tulane Univ School of Medicine

    New Orleans, Louisiana, 70112

  • 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 compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have already received at least 1 year of AZT therapy and to define the safety profile.

ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT.

Read the detailed description

ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT.

AMENDED: AZT will be administered orally every 4 or 5 hours. Patients in the second arm discontinue AZT and take ddC as two tablets every 8 hours. Duration of the study is 1 year with interim analysis done at 6 months after 75 percent enrollment and at end of the study. Original design: Patients with AIDS or advanced ARC who have been receiving at least 500 mg/day of AZT for at least 48 weeks are randomized to 1 of 2 treatment arms. Patients in the first treatment arm continue their current dose of AZT.

Conditions
HIV Infections
Being tested
Zidovudine, 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.

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)
  2. Primary completionJul 1992

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)
Enrolment
320 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000678
Sponsor's protocol ID
ACTG 119
Other IDs
N3492B
Status last verified
Sep 1992
First submitted
2 Nov 1999
Last updated
14 Mar 2011
Results posted
No

Publications

  • Fischl MA, Olson RM, Follansbee SE, Lalezari JP, Henry DH, Frame PT, Remick SC, Salgo MP, Lin AH, Nauss-Karol C, Lieberman J, Soo W. Zalcitabine compared with zidovudine in patients with advanced HIV-1 infection who received previous zidovudine therapy. Ann Intern Med. 1993 May 15;118(10):762-9. doi: 10.7326/0003-4819-118-10-199305150-00002.

    PubMed 8097082

  • Gries JM, Troconiz IF, Verotta D, Jacobson M, Sheiner LB. A pooled analysis of CD4 response to zidovudine and zalcitabine treatment in patients with AIDS and AIDS-related complex. Clin Pharmacol Ther. 1997 Jan;61(1):70-82. doi: 10.1016/S0009-9236(97)90183-1.

    PubMed 9024175

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 20 inclusion and 20 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 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 NCT00000678, which also lists 2 linked publications.

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 14 Mar 2011.

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