Know Cancer

forgot password

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 CRS Birmingham, Alabama  35294
UCLA CARE Center CRS Los Angeles, California  90095
USC CRS Los Angeles, California  90033
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland, California  94609
Stanford CRS Palo Alto, California  94305
UCSD Maternal, Child, and Adolescent HIV CRS San Diego, California  92093
Ucsd, Avrc Crs San Diego, California  
Ucsf Aids Crs San Francisco, California  
Santa Clara Valley Med. Ctr. San Jose, California  95128
San Mateo County AIDS Program San Mateo, California  94305
Harbor-UCLA Med. Ctr. CRS Torrance, California  90502
University of Colorado Hospital CRS Aurora, Colorado  80262
Howard University Hosp., Div. of Infectious Diseases, ACTU Washington, District of Columbia  20059
Univ. of Miami AIDS CRS Miami, Florida  33136
Emory Univ. Hemophilia Program Office Atlanta, Georgia  30365
Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu, Hawaii  96816
Northwestern University CRS Chicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRS Chicago, Illinois  60612
Cook County Hosp. CORE Ctr. Chicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis, Indiana  46202
Methodist Hosp. of Indiana Indianapolis, Indiana  46202
Univ. of Iowa Healthcare, Div. of Infectious Diseases Iowa City, Iowa  52242
Tulane Hemophilia Treatment Ctr. New Orleans, Louisiana  70112
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU New Orleans, Louisiana  70112
Tulane/LSU Maternal/Child CRS 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
Hennepin County Med. Ctr., Div. of Infectious Diseases Minneapolis, Minnesota  55455
University of Minnesota, ACTU Minneapolis, Minnesota  
St. Louis ConnectCare, Infectious Diseases Clinic St Louis, Missouri  63112
Washington U CRS St. Louis, Missouri  
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. Omaha, Nebraska  
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
Wake County Health and Human Services CRS Raleigh, North Carolina  27610
Univ. of Cincinnati CRS Cincinnati, Ohio  45267
Case CRS Cleveland, Ohio  44106
MetroHealth CRS Cleveland, Ohio  
The Ohio State Univ. AIDS CRS Columbus, Ohio  43210
Hosp. of the Univ. of Pennsylvania CRS Philadelphia, Pennsylvania  19104
University of Washington AIDS CRS Seattle, Washington  98122