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A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3

Phase 2
12 Years
Not Enrolling
HIV Infections

Thank you

Trial Information

A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3

Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at
least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of
baseline are crossed over to another treatment arm.

PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for
patients still taking study medications on 4/30/95, so that follow-up trials may be
completed and approved.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- PCP prophylaxis, M. tuberculosis prophylaxis, short courses of acyclovir, chronic
suppressive acyclovir, pneumovax or Hib vaccine, antibiotics, rEPO and G-CSF for
grade 3 or worse anemia and neutropenia, systemic corticosteroids for < 21 days,
regularly prescribed medications, and vitamins or herbal therapies.

Patients must have:

- HIV infection without AIDS with CD4 200-500 cells/mm3.


- Patients must have remained on ACTG 175 study treatment through 4/30/95 and meet
toxicity management criteria for continuing treatment. Subjects taking ACTG 175
crossover treatment are eligible.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

- Current AIDS-related condition other than minimal KS, grade 2 or worse peripheral
neuropathy, and malignancy requiring systemic therapy.

Concurrent Medication:


- Other anti-HIV drugs, biologic response modifiers other than rEPO and G-CSF, systemic
cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects
AZT glucuronidation or clearance.

Concurrent Treatment:


- Radiotherapy other than limited local therapy to skin.

Patients with the following prior conditions are excluded:

- AIDS-related condition other than minimal KS; intolerance to AZT, ddI, or ddC at
study doses; and acute or chronic pancreatitis.

Prior Medication:


- Acute therapy for an infection or other medical illness within the past 14 days.

Current alcohol abuse.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Katzenstein D

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 175



Start Date:

Completion Date:

November 1995

Related Keywords:

  • HIV Infections
  • Zalcitabine
  • Didanosine
  • Drug Therapy, Combination
  • AIDS-Related Complex
  • Antiviral Agents
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



Alabama Therapeutics CRSBirmingham, Alabama  35294
UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.Oakland, California  94609
Stanford CRSPalo Alto, California  94305
UCSD Maternal, Child, and Adolescent HIV CRSSan Diego, California  92093
Ucsd, Avrc CrsSan Diego, California  
Ucsf Aids CrsSan Francisco, California  
Santa Clara Valley Med. Ctr.San Jose, California  95128
San Mateo County AIDS ProgramSan Mateo, California  94305
Harbor-UCLA Med. Ctr. CRSTorrance, California  90502
University of Colorado Hospital CRSAurora, Colorado  80262
Howard University Hosp., Div. of Infectious Diseases, ACTUWashington, District of Columbia  20059
Univ. of Miami AIDS CRSMiami, Florida  33136
Emory Univ. Hemophilia Program OfficeAtlanta, Georgia  30365
Univ. of Hawaii at Manoa, Leahi Hosp.Honolulu, Hawaii  96816
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Cook County Hosp. CORE Ctr.Chicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Methodist Hosp. of IndianaIndianapolis, Indiana  46202
Univ. of Iowa Healthcare, Div. of Infectious DiseasesIowa City, Iowa  52242
Tulane Hemophilia Treatment Ctr.New Orleans, Louisiana  70112
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTUNew Orleans, Louisiana  70112
Tulane/LSU Maternal/Child CRSNew 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
Hennepin County Med. Ctr., Div. of Infectious DiseasesMinneapolis, Minnesota  55455
University of Minnesota, ACTUMinneapolis, Minnesota  
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.Omaha, Nebraska  
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
Wake County Health and Human Services CRSRaleigh, North Carolina  27610
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Case CRSCleveland, Ohio  44106
MetroHealth CRSCleveland, Ohio  
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210
Hosp. of the Univ. of Pennsylvania CRSPhiladelphia, Pennsylvania  19104
University of Washington AIDS CRSSeattle, Washington  98122