A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 mo...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Required:
- • PCP prophylaxis.
- Allowed:
- • Erythropoietin.
- • Prophylaxis for MAI or fungal infections.
- • Antibiotics.
- • Over-the-counter, alternative, or regularly prescribed drugs.
- • Steroids, if for \< 21 days.
- Concurrent Treatment:
- Allowed:
- • 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:
- Excluded:
- • 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:
- Excluded:
- • Non-study nucleosides or biologic response modifiers within 7 days prior to study entry.
- • 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 entry.
Trial Officials
WK Henry
Study Chair
JO Kahn
Study Chair
HH Balfour
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
San Mateo, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Miami, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
San Juan, , Puerto Rico
Mbeya, , Tanzania
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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