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HIV InfectionsPhase 2NCT00000679

(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC

A Phase 2 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 25 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 show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a different safety profile than AZT. In clinical studies, ddC shows antiviral activity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Zalcitabine
How many people
600 participants
Where
25 sitesUnited States
Study dates
Start not givento Feb 1994
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine (300 mg once every 4 weeks) for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Neuroleptics, benzodiazepines, or antidepressants if patient has been stable with chronic treatment > 1 month.
  • Low dose benzodiazepines or low dose antidepressants.
  • Drugs that are unlikely to cause increased toxicity with either study drug and are unlikely to cause peripheral neuropathy.
Show all 21Show fewer
  • Drugs with little nephrotoxicity, hepatotoxicity, or cytotoxicity that the patient has been taking and tolerating well.
  • Acyclovir (up to 600 mg/kg/day) for up to 21 days.
  • Ketoconazole (up to 400 mg/day) Nystatin.
  • Low-dose acetaminophen or nonsteroidal anti-inflammatory agents.
  • Isoniazid if patient has no evidence of peripheral neuropathy at entry and if patient takes 50 mg/day pyridoxine concomitantly with isoniazid.
  • Allowed with interruption of study medication for up to 21 days per episode and for a total of 42 days for the study:
  • Drugs that could cause serious additive toxicity when coadministered with either study medication for treatment of an acute intercurrent illness or opportunistic infection, including:
  • Acyclovir (< 600 mg/day), fluconazole, systemic pentamidine, foscarnet, pyrimethamine, triple sulfa, ansamycin, ganciclovir, trimethoprim / sulfamethoxazole.
  • Patients must have a diagnosis of AIDS or advanced AIDS related complex (ARC). At least 20 percent of the patients must have a consistently positive serum HIV p24 antigen (= or > 70 pg/ml) as defined by the Abbott HIV antigen test, on two separate occasions at least 72 hours apart.
  • Patients found at screening to have a temperature > 38.5 degrees C should be evaluated for the possibility of an occult opportunistic or bacterial infection or neoplasm. If this complete evaluation reveals an infection, they can be entered. If this evaluation is unrevealing, they may be entered after evaluation is completed but while mycobacterial cultures are still pending. Patients with a history of unexplained temperatures > 38.5 degrees C should be evaluated as above and/or be afebrile (temperature < 38.0 degrees C) for 2 weeks prior to study entry.
  • Allowed: Kaposi's sarcoma not specifically excluded, basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) if treated as for asymptomatic neurosyphilis.
  • Prior Medication:
  • Allowed:
  • Drugs that cause peripheral neuropathy and drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC) including experimental drugs if therapy with these drugs is completed and patient is stable for 14 days.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active AIDS defining opportunistic infection or other active intercurrent illness is excluded if ongoing treatment requires the use of excluded concomitant medication.
  • Patients with symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with current neoplasms not specifically allowed.
  • Severe AIDS dementia complex defined by a score of < 23 on the Mini-Mental State Exam.
  • Signs, symptoms, or history of peripheral neuropathy.
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  • Significant cardiac disease, defined as history of ventricular arrhythmias requiring medication, prior myocardial infarct, or history of angina or ischemia changes on ECG (electrocardiography).
  • Requiring > 2 weeks of acyclovir therapy at > 600 mg/day.
  • Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) not specifically allowed.
  • Significant liver disease.
  • Concurrent Medication:
  • Excluded:
  • Drugs that cause peripheral neuropathy:
  • chloramphenicol, cisplatinum, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, ribavirin, metronidazole, vincristine, nitrofurantoin.
  • Drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC), including experimental drugs not specifically allowed.
  • Drugs that could cause seizures or changes in mental status or neurological examination.
  • Concurrent Treatment:
  • Excluded:
  • Transfusion dependency.
  • Patients with the following are excluded:
  • Active AIDS defining opportunistic infection or other active intercurrent illness if ongoing treatment requires use of excluded concomitant medication.
  • Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or current neoplasms not specifically allowed.
  • Severe AIDS dementia complex defined by a score of < 23 on the Mini-Mental State Exam.
  • Signs, symptoms, or history of peripheral neuropathy.
  • Unwilling or unable to sign informed consent.
  • Prior Medication:
  • Excluded:
  • Zidovudine (AZT), dideoxycytidine (ddC), or any other antiretroviral nucleoside analog.
  • Excluded within 90 days of study entry:
  • Any experimental drug including fluconazole, ganciclovir, foscarnet, erythropoietin, or ribavirin.
  • Excluded within 90 days of study entry:
  • Drugs that have caused significant nephrotoxicity or significant hepatotoxicity.
  • Drugs that could cause peripheral neuropathy including phenytoin, hydralazine, metronidazole, and nitrofurantoin.
  • Systemic corticosteroids or immunomodulators including interferon and interleukin.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Radiation therapy.
  • Active substance or alcohol abuse.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Albany Med College / AIDS Treatment Ctr

    Albany, New York, 12203

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • New England Med Ctr

    Boston, Massachusetts, 02111

  • Sunset Park Health Ctr - Lutheran Med Ctr

    Brooklyn, New York, 11220

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Univ Hosp of Cleveland / Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • N Texas Ctr for AIDS & Clin Rsch

    Dallas, Texas, 75219

  • Henry Ford Hosp

    Detroit, Michigan, 48202

  • Ctr for Special Immunology

    Fort Lauderdale, Florida, 33308

  • Comprehensive Clinic / Dr Robert Schwartz

    Fort Myers, Florida, 33901

  • Univ TX Galveston Med Branch

    Galveston, Texas, 77550

  • Kaiser Foundation Hosp

    Harbor City, California, 90710

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Kaiser Permanente Med Ctr

    Los Angeles, California, 90027

  • Med Service

    Miami, Florida, 33125

  • Saint Michael's Med Ctr

    Newark, New Jersey, 07102

  • Graduate Hosp

    Philadelphia, Pennsylvania, 19146

  • UCD Med Ctr

    Sacramento, California, 95817

  • Davies Med Ctr

    San Francisco, California, 94114

  • Mount Zion Med Ctr

    San Francisco, California, 94115

  • San Francisco Veterans Administration Med Ctr

    San Francisco, California, 94121

  • Santa Clara Valley Med Ctr

    San Jose, California, 95128

  • Georgetown Univ Med Ctr

    Washington D.C., District of Columbia, 20007

  • Bowman Gray School of Medicine / North Carolina Baptist Hosp

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a different safety profile than AZT.

In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted.

Read the detailed description

In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted.

After screening, physical examination and laboratory tests (within 14 days of entry) patients are randomized to one of two treatment groups. They receive either ddC plus an AZT placebo or AZT plus a ddC placebo. Because it is a blinded study, patients do not know which group they are in. Patients are evaluated weekly for the first 10 weeks and then biweekly thereafter.

Conditions
HIV Infections
Being tested
Zidovudine, Zalcitabine
Keywords
Zalcitabine, 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 completionFeb 1994

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
Double blind
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000679
Sponsor's protocol ID
ACTG 114
Other IDs
Protocol Number: N3300A, FDA 31A, Study Number: 3-27
Status last verified
Dec 1994
First submitted
2 Nov 1999
Last updated
14 Mar 2011
Results posted
No

Publications

  • Bozzette SA, Hays RD, Berry SH, Kanouse DE. A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care. 1994 Jul;32(7):716-31. doi: 10.1097/00005650-199407000-00005.

    PubMed 8028406

  • Bozzette SA, Hays RD, Berry SH, Kanouse DE, Wu AW. Derivation and properties of a brief health status assessment instrument for use in HIV disease. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Mar 1;8(3):253-65. doi: 10.1097/00042560-199503010-00006.

    PubMed 7859137

  • Bozzette SA, Kanouse DE, Berry S, Duan N. Health status and function with zidovudine or zalcitabine as initial therapy for AIDS. A randomized controlled trial. Roche 3300/ACTG 114 Study Group. JAMA. 1995 Jan 25;273(4):295-301.

    PubMed 7815656

  • Bozzette SA, Kanouse D, Berry S, Duan N, Downes-LeGuin T, Hays R, Petinnelli C, Richman DD, Gocke D, Kahn J. Relative effects of ddC or ddI versus ZDV on health status, function and disability in N3300 (ACTG 114) and ACTG 116b/117. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo21 (abstract no MoB 0077)

  • Remick S, Follansbee S, Olson R, Pollard R, Reiter W, Salgo M. Safety and tolerance of zalcitabine (ddC, HIVID) in a double-blind, comparative trial (ACTG 114; N3300). Int Conf AIDS. 1993 Jun 6-11;9(1):488 (abstract no PO-B26-2115)

  • Follansbee S, Drew L, Olson R, Pollard R, Relter W, Salgo M. The efficacy of zalcitabine (ddC, HIVID) versus zidovudine (ZDV) as monotherapy in ZDV naive patients with advanced HIV disease: a randomized, double-blind, comparative trial (ACTG 114; N3300). Int Conf AIDS. 1993 Jun 6-11;9(1):487 (abstract no PO-B26-2113)

  • 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 25 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 21 inclusion and 38 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 25 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 NCT00000679, which also lists 7 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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Clinical Trial NCT00000679 | AzTrials