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A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy

Phase 2
13 Years
Not Enrolling
HIV Infections

Thank you

Trial Information

A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy

Combining two nucleoside drugs has the theoretical advantage of optimal protection against
the evolution of resistant strains of HIV. However, one major problem with combination
nucleoside therapy in patients with advanced disease is the increased toxicity resulting
from such therapy. One approach to minimize toxicity while perhaps retaining some of the
benefits of combination therapy is to alternate the two drugs.

Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT
alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly
with ddI will start with AZT, while the other half will start with ddI. Treatment continues
until death or termination of the study. Patients are followed every 4 weeks. The study will
include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic
assessments will be made.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- PCP prophylaxis.


- Erythropoietin.

- Prophylaxis for MAI or fungal infections.

- Antibiotics.

- Over-the-counter, alternative, or regularly prescribed drugs.

- Steroids, if for < 21 days.

Concurrent Treatment:


- Radiation therapy for cutaneous Kaposi's sarcoma.

Patients must have:

- HIV infection.

- CD4 count <= 50 cells/mm3.

- Prior nucleoside monotherapy for at least 6 months.

- Life expectancy of at least 6 months.

Prior Medication: Required:

- Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Severe peripheral neuropathy.

- Psychological or emotional problems sufficient to prevent study compliance.

Concurrent Medication:


- Systemic chemotherapy for malignancy.

- Acute or induction therapy for opportunistic infection.

Patients with the following prior conditions are excluded:

- History of acute or chronic pancreatitis.

- Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.

Prior Medication:


- Non-study nucleosides or biologic response modifiers within 7 days prior to study

- Acute therapy for opportunistic process within 14 days prior to study entry.

- Acute systemic therapy for other medical conditions within 14 days prior to study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

WK Henry

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 193



Start Date:

Completion Date:

May 1993

Related Keywords:

  • HIV Infections
  • Zalcitabine
  • Didanosine
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



USC CRS Los Angeles, California  90033
Stanford CRS Palo Alto, California  94305
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
Univ. of Miami AIDS CRS Miami, Florida  33136
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
Massachusetts General Hospital ACTG CRS Boston, Massachusetts  02114
Beth Israel Deaconess - East Campus A0102 CRS Boston, Massachusetts  02215
Bmc Actg Crs Boston, Massachusetts  02118
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  
NY Univ. HIV/AIDS CRS New York, New York  10016
Memorial Sloan-Kettering Cancer Ctr. New York, New York  10021
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
Univ. of Cincinnati CRS Cincinnati, Ohio  45267
Case CRS Cleveland, Ohio  44106
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