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AzTrials

HIV InfectionsPhase 3NCT00000651

A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy

A Phase 3 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 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 evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with zidovudine (AZT) versus AZT alone when administered to asymptomatic patients with a CD4 count = or < 200 cells/mm3 and symptomatic patients with a CD4 count = or < 300 cells/mm3. 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
750 participants
Where
40 sitesUnited States
Study dates
Start not givento May 1993
Phase
Phase 3
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:
  • Zidovudine (AZT) = or > 300 mg/day for 6 weeks prior to study entry.
  • Allowed:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP), candidiasis, and herpes.
  • 21 day course of adjuvant systemic corticosteroids for moderate to severe PCP.
Show all 16Show fewer
  • Maintenance treatment with pyrimethamine, sulfadiazine, amphotericin, fluconazole, ketoconazole, acyclovir, ganciclovir, or 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.
  • 14 day course of metronidazole.
  • Erythropoietin and megace if clinically indicated.
  • Isoniazid if patient has no peripheral neuropathy at entry and is taking pyridoxine = or > 50 mg/day concomitantly.
  • Phenytoin if patient has < grade 2 peripheral neuropathy at entry and has been stable on phenytoin = or > 3 months.
  • Patients must have:
  • Ability and willingness to give informed consent.
  • Written informed consent from a parent or guardian if < 18 years old.
  • Been tolerating zidovudine (AZT) therapy.
  • Diagnosis of HIV infection.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Kaposi's sarcoma or other malignancy requiring therapy.
  • Active opportunistic infections.
  • Peripheral neuropathy as manifested by complaints of moderate pain, burning, numbness, or tingling in hands/arms or feet/legs; moderate sensory deficit in the upper or lower extremities; or motor weakness in the upper or lower extremities.
  • Concurrent Medication:
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  • Excluded:
  • Other experimental medications.
  • Other anti-HIV drugs.
  • Biologic response modifiers.
  • Cytotoxic chemotherapy.
  • Drugs that could cause peripheral neuropathy including phenytoin not specifically allowed, hydralazine, nitrofurantoin, vincristine, cisplatinum, dapsone, disulfiram, and diethyldithiocarbamate.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients with the following are excluded:
  • Active opportunistic infection. Must have ended acute therapy at least 14 days prior to study entry.
  • Peripheral neuropathy = or > grade 2.
  • History of intolerance to 500 to 600 mg/day of zidovudine (AZT) as manifested by the same recurrent grade 3 toxicity requiring dose interruptions and dose reductions to < 500 mg/day or any prior grade 4 toxicity.
  • Prior development of peripheral neuropathy on ddI = or > grade 2.
  • Prior Medication:
  • Excluded:
  • Dideoxycytidine (ddC).
  • Required:
  • Zidovudine (AZT) for total of at least 24 weeks; and included within that time period, AZT = or > 300 mg/day for 6 weeks prior to the study entry.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital ACTG CRS

    Boston, Massachusetts, 02114

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases

    Boston, Massachusetts, 02115

  • Bmc Actg Crs

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - East Campus A0102 CRS

    Boston, Massachusetts, 02215

  • Beth Israel Deaconess Med. Ctr., ACTG CRS

    Boston, Massachusetts, 02215

  • Brigham and Women's Hosp., Div. of Infectious Disease

    Boston, Massachusetts

  • SUNY - Buffalo, Erie County Medical Ctr.

    Buffalo, New York, 14215

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27599

  • Carolinas HealthCare System, Carolinas Med. Ctr.

    Charlotte, North Carolina

  • Northwestern University CRS

    Chicago, Illinois

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio, 45267

  • Case CRS

    Cleveland, Ohio, 44106

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio, 43210

  • Duke Univ. Med. Ctr. Adult CRS

    Durham, North Carolina, 27710

  • Regional Center for Infectious Disease, Wendover Medical Center CRS

    Greensboro, North Carolina

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, 46202

  • USC CRS

    Los Angeles, California, 90033

  • UCLA CARE Center CRS

    Los Angeles, California, 90095

  • Univ. of Miami AIDS CRS

    Miami, Florida, 33136

  • University of Minnesota, ACTU

    Minneapolis, Minnesota, 55455

  • Tulane Hemophilia Treatment Ctr.

    New Orleans, Louisiana

  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU

    New Orleans, Louisiana

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York, 10016

  • Cornell University A2201

    New York, New York, 10021

  • Memorial Sloan-Kettering Cancer Ctr.

    New York, New York, 10021

  • Beth Israel Med. Ctr. (Mt. Sinai)

    New York, New York, 10029

  • NY Univ. HIV/AIDS CRS

    New York, New York

  • NJ Med. School CRS

    Newark, New Jersey, 07103

  • Pitt CRS

    Pittsburgh, Pennsylvania, 15213

  • Univ. of Rochester ACTG CRS

    Rochester, New York

  • UCSD Maternal, Child, and Adolescent HIV CRS

    San Diego, California, 92103

  • Ucsd, Avrc Crs

    San Diego, California

  • Ucsf Aids Crs

    San Francisco, California

  • University of Washington AIDS CRS

    Seattle, Washington, 98122

  • St. Louis ConnectCare, Infectious Diseases Clinic

    St Louis, Missouri

  • Washington U CRS

    St Louis, Missouri

  • Harbor-UCLA Med. Ctr. CRS

    Torrance, California, 90502

Other trials in United States

About this study

To evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with zidovudine (AZT) versus AZT alone when administered to asymptomatic patients with a CD4 count = or < 200 cells/mm3 and symptomatic patients with a CD4 count = or < 300 cells/mm3. To compare the effectiveness of ddC alone and in combination with AZT versus AZT alone.

ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly decrease mortality and 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. Because of the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted.

Read the detailed description

ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly decrease mortality and 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. Because of the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted.

Patients are randomly assigned to 1 of 3 treatment groups. In study arm 1, patients receive AZT plus ddC placebo. In study arm 2, patients receive ddC plus AZT placebo capsules. In study arm 3, patients receive ddC plus AZT. Patients are seen every other week for first 8 weeks and monthly thereafter. Patients are stratified by HIV disease status, length of time receiving AZT, and systemic or local Pneumocystis carinii pneumonia (PCP) prophylaxis. Patients who reach a clinical AIDS-defining endpoint are offered open-label combination therapy.

Conditions
HIV Infections
Being tested
Zidovudine, Zalcitabine
Keywords
Zalcitabine, Antiviral Agents, Zidovudine
Medical subject headings
HIV Infections

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. Study completionMay 1993

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 3
Primary purpose
Treatment
Masking
Double blind
Enrolment
750 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000651
Sponsor's protocol ID
ACTG 155
Other IDs
11130
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
2 Nov 2021
Results posted
No

Publications

  • Blum AS, Dal Pan GJ, Feinberg J, Raines C, Mayjo K, Cornblath DR, McArthur JC. Low-dose zalcitabine-related toxic neuropathy: frequency, natural history, and risk factors. Neurology. 1996 Apr;46(4):999-1003. doi: 10.1212/wnl.46.4.999.

    PubMed 8780079

  • Fichtenbaum CJ, Clifford DB, Powderly WG. Risk factors for dideoxynucleoside-induced toxic neuropathy in patients with the human immunodeficiency virus infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Oct 1;10(2):169-74. doi: 10.1097/00042560-199510020-00009.

    PubMed 7552481

  • Fischl M, Collier A, Stanley K, Ardunio JM, Kazial K, Stein D. The safety and efficacy of zidovudine (ZDV) and zalcitabine (ddC) or ddC alone versus ZDV. ACTG 155 Team of the NIAID. Int Conf AIDS. 1993 Jun 6-11;9(1):68 (abstract no WS-B25-1)

  • Keruly J, Kendig N, Feinberg J, Cotton S, Biggs M, Benjamin Y, Francis H, Wade W, Coplin M, Bartlett J. A model for conducting AIDS clinical trials in a state correctional system. Int Conf AIDS. 1992 Jul 19-24;8(2):B236 (abstract no PoB 3873)

  • Johnson VA. Combination therapy: more effective control of HIV type 1? AIDS Res Hum Retroviruses. 1994 Aug;10(8):907-12. doi: 10.1089/aid.1994.10.907.

    PubMed 7811541

  • Fischl MA, Stanley K, Collier AC, Arduino JM, Stein DS, Feinberg JE, Allan JD, Goldsmith JC, Powderly WG. Combination and monotherapy with zidovudine and zalcitabine in patients with advanced HIV disease. The NIAID AIDS Clinical Trials Group. Ann Intern Med. 1995 Jan 1;122(1):24-32. doi: 10.7326/0003-4819-122-1-199501010-00004.

    PubMed 7985892

  • Spino C, Kahn JO, Dolin R, Phair JP. Predictors of survival in HIV-infected persons with 50 or fewer CD4 cells/mm3. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Aug 15;15(5):346-55. doi: 10.1097/00042560-199708150-00004.

    PubMed 9342254

  • Zackin RA, Clark RA, Currier JS, Mildvan D. Predictive markers of HIV-related weight loss and determination of differences between populations with weight loss stratified by opportunistic processes. J Acquir Immune Defic Syndr. 1999 Oct 1;22(2):189-93. doi: 10.1097/00126334-199910010-00012.

    PubMed 10843534

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 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 16 inclusion and 25 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT00000651, which also lists 8 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 2 Nov 2021.

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