(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
4 other identifiers
interventional
600
1 country
25
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
February 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 14, 2011
December 1, 1994
November 2, 1999
March 11, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +6 more criteria
You may not qualify if:
- 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.
- 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.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Kaiser Foundation Hosp
Harbor City, California, 90710, United States
Kaiser Permanente Med Ctr
Los Angeles, California, 90027, United States
UCD Med Ctr
Sacramento, California, 95817, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Santa Clara Valley Med Ctr
San Jose, California, 95128, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, 33308, United States
Comprehensive Clinic / Dr Robert Schwartz
Fort Myers, Florida, 33901, United States
Med Service
Miami, Florida, 33125, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102, United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203, United States
Sunset Park Health Ctr - Lutheran Med Ctr
Brooklyn, New York, 11220, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, 27103, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146, United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (7)
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.
PMID: 8028406BACKGROUNDBozzette 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.
PMID: 7859137BACKGROUNDBozzette 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.
PMID: 7815656BACKGROUNDBozzette 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)
BACKGROUNDRemick 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)
BACKGROUNDFollansbee 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)
BACKGROUNDGries 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.
PMID: 9024175BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
February 1, 1994
Last Updated
March 14, 2011
Record last verified: 1994-12