A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
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
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while mi...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Required:
- • PCP prophylaxis.
- Allowed:
- • Erythropoietin maintenance.
- • G-CSF and GM-CSF.
- • Prophylaxis for Mycobacterium avium intracellulare.
- • Antifungal prophylaxis or treatment with specific drugs.
- • Maintenance therapy for opportunistic infection.
- • Over-the-counter medications or alternative therapies such as vitamins and herbs.
- • Antibiotics as clinically indicated.
- • Steroids for \< 21 days for acute problems.
- • Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications.
- Concurrent Treatment:
- Allowed:
- • Radiation therapy for cutaneous Kaposi's sarcoma.
- • Acupuncture.
- Patients must have:
- • Documented HIV infection.
- • CD4 count \<= 50 cells/mm3.
- • Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance.
- • Life expectancy of at least 6 months.
- • Consent of parent or guardian if \< 18 years of age.
- • Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment).
- NOTE:
- • Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- • Abnormal baseline chest x-ray.
- • New pulmonary or cardiac symptoms.
- • Psychological or emotional problems sufficient to prevent compliance with study medication.
- Concurrent Medication:
- Excluded:
- • Systemic chemotherapy for malignancy.
- • Acute or induction therapy for opportunistic infection.
- • Antiretroviral drugs other than study drugs.
- • Biological response modifiers.
- • Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin.
- Patients with the following prior conditions are excluded:
- • History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.
- • Evidence of active pulmonary disease within 6 months prior to study entry.
- • History of grade 3 or worse peripheral neuropathy.
- • History of acute or chronic pancreatitis.
- Prior Medication:
- Excluded:
- • Prior nevirapine.
- Excluded within 7 days prior to study entry:
- • Acute therapy for opportunistic infection (maintenance therapy is permitted).
- • Acute systemic therapy for a nonopportunistic infection or other medical condition.
- • Antiretroviral drugs other than AZT, ddI, or ddC.
- • Biological response modifiers.
- • d4T therapy.
- • Nucleosides other than those used in the study.
- • Antibiotics containing clavulanate potassium.
- Prior Treatment:
- Excluded:
- • More than 4 units of blood in a 30-day period.
- • Active alcohol or drug abuse.
Trial Officials
Henry WK
Study Chair
Kahn JO
Study Chair
Balfour HH
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
Birmingham, Alabama, United States
Los Angeles, California, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Worcester, Massachusetts, United States
Saint Louis, Missouri, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
West Columbia, South Carolina, United States
San Francisco, California, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Seattle, Washington, United States
Pasadena, California, United States
San Diego, California, United States
Washington, District Of Columbia, United States
Chicago, Illinois, United States
New Brunswick, New Jersey, 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
Cleveland, Ohio, United States
Columbus, Ohio, United States
Los Angeles, California, United States
San Francisco, California, United States
San Jose, California, United States
Stanford, California, United States
Stanford, California, United States
Sylmar, California, United States
Torrance, California, United States
New Haven, Connecticut, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
Newark, New Jersey, United States
Albany, New York, United States
Albany, New York, United States
Albany, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Elmhurst, New York, United States
Manhasset, New York, United States
New York, New York, United States
Syracuse, New York, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Galveston, Texas, United States
San Juan, , Puerto Rico
San Francisco, California, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Denver, Colorado, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Toledo, Ohio, United States
Hershey, Pennsylvania, United States
Knoxville, Tennessee, United States
Tampa, Florida, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Washington, District Of Columbia, United States
Houston, Texas, United States
Wauwatosa, Wisconsin, United States
Denver, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Louisville, Kentucky, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Hershey, Pennsylvania, United States
Green Bay, Wisconsin, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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