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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
N/A
Not Enrolling
Both
HIV Infections

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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
therapy.

Inclusion Criteria


Inclusion Criteria

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.

- 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:

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.

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:

Excluded:

- Dideoxycytidine (ddC).

Required:

- 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:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

M Fischl

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 155

NCT ID:

NCT00000651

Start Date:

Completion Date:

May 1993

Related Keywords:

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

Name

Location

UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
UCSD Maternal, Child, and Adolescent HIV CRSSan Diego, California  92093
Ucsd, Avrc CrsSan Diego, California  
Ucsf Aids CrsSan Francisco, California  
Harbor-UCLA Med. Ctr. CRSTorrance, California  90502
University of Colorado Hospital CRSAurora, Colorado  80262
Univ. of Miami AIDS CRSMiami, Florida  33136
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Tulane Hemophilia Treatment Ctr.New Orleans, Louisiana  70112
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTUNew Orleans, Louisiana  70112
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Massachusetts General Hospital ACTG CRSBoston, Massachusetts  02114
Beth Israel Deaconess - East Campus A0102 CRSBoston, Massachusetts  02215
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
HMS - Children's Hosp. Boston, Div. of Infectious DiseasesBoston, Massachusetts  02115
Brigham and Women's Hosp., Div. of Infectious DiseaseBoston, Massachusetts  02115
University of Minnesota, ACTUMinneapolis, Minnesota  
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
NJ Med. School CRSNewark, New Jersey  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
NY Univ. HIV/AIDS CRSNew York, New York  10016
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
NYU Med. Ctr., Dept. of MedicineNew York, New York  
Cornell University A2201New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai)New York, New York  10003
Univ. of Rochester ACTG CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Carolinas HealthCare System, Carolinas Med. Ctr.Charlotte, North Carolina  28203
Duke Univ. Med. Ctr. Adult CRSDurham, North Carolina  27710
Regional Center for Infectious Disease, Wendover Medical Center CRSGreensboro, North Carolina  27401
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Case CRSCleveland, Ohio  44106
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210
University of Washington AIDS CRSSeattle, Washington  98122
Pitt CRSPittsburgh, Pennsylvania  15213