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
2 other identifiers
interventional
750
1 country
40
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
May 1, 1993
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 2, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- day course of adjuvant systemic corticosteroids for moderate to severe PCP.
- 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.
- 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.
- +1 more criteria
You may not qualify if:
- 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:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Hoffmann-La Rochecollaborator
- Glaxo Wellcomecollaborator
Study Sites (40)
USC CRS
Los Angeles, California, 90033, United States
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 92103, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136, United States
Northwestern University CRS
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
Brigham and Women's Hosp., Div. of Infectious Disease
Boston, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
NJ Med. School CRS
Newark, New Jersey, 07103, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016, United States
Cornell University A2201
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10029, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27599, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267, United States
Case CRS
Cleveland, Ohio, 44106, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213, United States
University of Washington AIDS CRS
Seattle, Washington, 98122, United States
Related Publications (8)
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.
PMID: 8780079BACKGROUNDFichtenbaum 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.
PMID: 7552481BACKGROUNDFischl 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)
BACKGROUNDKeruly 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)
BACKGROUNDJohnson 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.
PMID: 7811541BACKGROUNDFischl 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.
PMID: 7985892BACKGROUNDSpino 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.
PMID: 9342254BACKGROUNDZackin 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.
PMID: 10843534BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
M Fischl
- STUDY CHAIR
A Collier
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 1993
Last Updated
November 2, 2021
Record last verified: 2021-10