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AzTrials

HIV InfectionsPhase 2NCT00000653

A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT

A Phase 2 study testing Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 35 sites in 2 countries.

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 and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT… Read more about this study

Who is it for?
Ages 3 months to 18 years
Conditions the study is for
HIV Infections
What is being tested?
Zalcitabine
How many people
140 participants
Where
35 sitesin 2 countries
Study dates
Start not givento Jun 1995
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 3 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Procrit.
  • Amphotericin B (1 mg/kg up to 5 days/week).
  • Prophylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia.
  • Acyclovir (up to 1000 mg/day PO; for > 1000 mg/day PO or for any IV dose, suggest interrupting ddC).
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  • Ketoconazole (up to 10 mg/kg/day).
  • Nystatin.
  • Aspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours).
  • Isoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25
  • 50 mg/day to avoid possible INH-associated neuropathy.
  • Trimethoprim / sulfamethoxazole (T/S).
  • Immunoglobulin therapy.
  • Aerosolized pentamidine.
  • Drugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition.
  • Concurrent Treatment:
  • Allowed:
  • Immunoglobulin therapy.
  • Nutritional support (for children with wasting syndrome and/or malnutritional) including hyperalimentation (TPN) of dietary supplements.
  • AMENDED:
  • Patients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study.
  • ORIGINAL design:
  • Patients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol.
  • Patients must have the following:
  • Absence of acute opportunistic infection at time of entry.
  • However, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for > 4 weeks are eligible.
  • Parent or guardian available to give written informed consent.
  • Allowed at time of study entry:
  • Prophylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP).
  • Immunoglobulin therapy.
  • Prior Medication:
  • AMENDED:
  • AZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry
  • Allowed:
  • Zidovudine (AZT) within 4 weeks of entry.
  • Dideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI.
  • Other toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC.
  • Vitamin, folate, iron supplements.

Who cannot join

  • Co-existing Condition:
  • AMENDED:
  • 04-25-91 Additional excluded symptoms and conditions:
  • Symptomatic cardiomyopathy.
  • Seizures which are not well controlled by ongoing anticonvulsant therapy.
  • Active malignancy requiring concomitant chemotherapy.
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  • Symptomatic pancreatitis.
  • Grade I or greater peripheral neuropathy.
  • Receiving concomitant zidovudine (AZT).
  • Patients with the following conditions or symptoms are excluded:
  • Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
  • Known hypersensitivity to dideoxycytidine (ddC).
  • Concurrent Medication:
  • Excluded:
  • Other antiviral agents, biological modifiers, and investigational medications.
  • Drugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin.
  • Patients with the following are excluded:
  • Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
  • Known hypersensitivity to dideoxycytidine (ddC).
  • Active opportunistic infection requiring treatment with an excluded concomitant medication.
  • Prior Medication:
  • Excluded:
  • Antiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry.
  • Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
  • Any other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States32 sites

  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

    Atlanta, Georgia, 30303

  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

    Baltimore, Maryland, 21287

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

    Boston, Massachusetts, 02115

  • BMC, Div. of Ped Infectious Diseases

    Boston, Massachusetts, 02118

  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

    Brooklyn, New York, 11203

  • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases

    Chapel Hill, North Carolina, 27599

  • Cook County Hosp.

    Chicago, Illinois, 60612

  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

    Chicago, Illinois, 60612

  • Chicago Children's CRS

    Chicago, Illinois, 60614

  • DUMC Ped. CRS

    Durham, North Carolina, 27710

  • North Shore-Long Island Jewish Health System, Dept. of Peds.

    Great Neck, New York

  • Texas Children's Hosp. CRS

    Houston, Texas, 77030

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

    Los Angeles, California, 90095

  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS

    Miami, Florida, 33161

  • UMDNJ - Robert Wood Johnson

    New Brunswick, New Jersey

  • Schneider Children's Hosp., Div. of Infectious Diseases

    New Hyde Park, New York, 11042

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

    New Orleans, Louisiana

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York, 10016

  • Metropolitan Hosp. NICHD CRS

    New York, New York, 10029

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Harlem Hosp. Ctr. NY NICHD CRS

    New York, New York, 10037

  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

    Oakland, California, 94609

  • St. Christopher's Hosp. for Children

    Philadelphia, Pennsylvania, 19134

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • UCSD Maternal, Child, and Adolescent HIV CRS

    San Diego, California, 92093

  • UCSF Pediatric AIDS CRS

    San Francisco, California, 94143

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199

  • Bronx-Lebanon Hosp. IMPAACT CRS

    The Bronx, New York, 10456

  • Children's National Med. Ctr., ACTU

    Washington D.C., District of Columbia, 20010

  • WNE Maternal Pediatric Adolescent AIDS CRS

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico3 sites

  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

    Bayamón, 00619

  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

    San Juan, 00936

  • San Juan City Hosp. PR NICHD CRS

    San Juan

Other trials in Puerto Rico

About this study

To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy.

As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.

Read the detailed description

As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.

Patients receive oral ddC for 48 to 177 weeks.

Conditions
HIV Infections
Being tested
Zalcitabine
Keywords
Zalcitabine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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)
  2. Study completionJun 1995

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
Enrolment
140 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000653
Sponsor's protocol ID
ACTG 138
Other IDs
11113
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
27 Oct 2021
Results posted
No

Publications

  • Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

    PubMed 21037891

  • Spector SA, Blanchard S, Connor EM, Salgo MP, McNamara J. Results of a clinical trial comparing two doses of 2'3'-dideoxycytidine (ddC) in the treatment of children with symptomatic human immunodeficiency virus (HIV) infection who were intolerant or had failed zidovudine (ZDV) therapy (ACTG 138). The Pediatric AIDS Clinical Trials Group. American Pediatric Society 104th annual meeting and Society for Pediatric Research 63rd annual meeting; 1994 May 2-5; Seattle. Pediatr AIDS HIV Infect. 1994 Oct;5(5):323 (unnumbered abstract)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zalcitabine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 35 sites in 2 countries.

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 38 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Puerto Rico. 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 NCT00000653, 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 27 Oct 2021.

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