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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

Phase 3
13 Years
Not Enrolling
HIV Infections

Thank you

Trial Information

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

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

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- Zidovudine (AZT) = or > 300 mg/day for 6 weeks prior to study entry.


- Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP), candidiasis, and herpes.

- 21 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.

- 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.

Exclusion Criteria

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:


- 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:


- 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:


- Dideoxycytidine (ddC).


- 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.

Type of Study:


Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

M Fischl

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 155



Start Date:

Completion Date:

May 1993

Related Keywords:

  • HIV Infections
  • Zalcitabine
  • Antiviral Agents
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



UCLA CARE Center CRS Los Angeles, California  90095
USC CRS Los Angeles, California  90033
UCSD Maternal, Child, and Adolescent HIV CRS San Diego, California  92093
Ucsd, Avrc Crs San Diego, California  
Ucsf Aids Crs San Francisco, California  
Harbor-UCLA Med. Ctr. CRS Torrance, California  90502
University of Colorado Hospital CRS Aurora, Colorado  80262
Univ. of Miami AIDS CRS Miami, Florida  33136
Northwestern University CRS Chicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRS Chicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis, Indiana  46202
Tulane Hemophilia Treatment Ctr. New Orleans, Louisiana  70112
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU New Orleans, Louisiana  70112
Johns Hopkins Adult AIDS CRS Baltimore, Maryland  21287
Massachusetts General Hospital ACTG CRS Boston, Massachusetts  02114
Beth Israel Deaconess - East Campus A0102 CRS Boston, Massachusetts  02215
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston, Massachusetts  02215
Bmc Actg Crs Boston, Massachusetts  02118
HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston, Massachusetts  02115
Brigham and Women's Hosp., Div. of Infectious Disease Boston, Massachusetts  02115
University of Minnesota, ACTU Minneapolis, Minnesota  
St. Louis ConnectCare, Infectious Diseases Clinic St Louis, Missouri  63112
Washington U CRS St. Louis, Missouri  
NJ Med. School CRS Newark, New Jersey  
SUNY - Buffalo, Erie County Medical Ctr. Buffalo, New York  14215
NY Univ. HIV/AIDS CRS New York, New York  10016
Memorial Sloan-Kettering Cancer Ctr. New York, New York  10021
NYU Med. Ctr., Dept. of Medicine New York, New York  
Cornell University A2201 New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai) New York, New York  10003
Univ. of Rochester ACTG CRS Rochester, New York  14642
Unc Aids Crs Chapel Hill, North Carolina  27599
Carolinas HealthCare System, Carolinas Med. Ctr. Charlotte, North Carolina  28203
Duke Univ. Med. Ctr. Adult CRS Durham, North Carolina  27710
Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro, North Carolina  27401
Univ. of Cincinnati CRS Cincinnati, Ohio  45267
Case CRS Cleveland, Ohio  44106
The Ohio State Univ. AIDS CRS Columbus, Ohio  43210
University of Washington AIDS CRS Seattle, Washington  98122
Pitt CRS Pittsburgh, Pennsylvania  15213