Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.
Initially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 yea...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Chemoprophylaxis for Pneumocystis carinii pneumonia.
- • Antibiotics, antifungals, and antiviral medications, as clinically indicated.
- • Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider.
- Concurrent Treatment:
- Allowed:
- • Limited localized radiation therapy to the skin.
- Prior Medication: Required:
- • AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry.
- Patients must have:
- • Asymptomatic HIV infection.
- • CD4 count 300-600 cells/mm3.
- • No plasma/serum PCR for codon 215 mutation at screening.
- • Prior AZT monotherapy.
- NOTE:
- • All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged.
- AS PER AMENDMENT 04/03/95:
- • DOD female patients must have a negative pregnancy test within 48 hours prior to study entry.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- • Symptomatic grade 2 or worse peripheral neuropathy.
- • Unable to swallow capsules and tablets.
- • Other medical condition that contraindicates study participation.
- Concurrent Medication:
- Excluded:
- • Systemic cytotoxic chemotherapy.
- • Biologic response modifiers (such as interferon, ampligen, or PEG-IL2).
- • Anti-HIV agents other than study drugs.
- • Other investigational agents.
- • Foscarnet unless clinically indicated for unresponsive herpes virus infection.
- • Chronic antacid or H-2 blocker use.
- • Rifampin or rifamycin class agents.
- • Antibiotics containing clavulanic acid.
- Concurrent Treatment:
- Excluded:
- • Radiation therapy other than limited localized therapy to skin.
- Patients with the following prior condition are excluded:
- • History of pancreatitis.
- Prior Medication:
- Excluded:
- • Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT.
- • Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening.
- Prior Treatment:
- Excluded:
- • Blood transfusion within the preceding 2 weeks.
- • Illicit drug or alcohol abuse.
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
Indianapolis, Indiana, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Columbus, Ohio, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Atlanta, Georgia, 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
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
San Francisco, California, United States
San Jose, California, United States
Stanford, California, United States
Stanford, California, United States
Torrance, California, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Omaha, Nebraska, 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
Buffalo, New York, United States
Syracuse, New York, United States
Raleigh, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Galveston, Texas, United States
Boston, Massachusetts, United States
Charlotte, North Carolina, United States
Los Angeles, California, United States
Minneapolis, Minnesota, United States
Denver, Colorado, United States
Toledo, Ohio, United States
Hershey, Pennsylvania, United States
Knoxville, Tennessee, United States
Iowa City, Iowa, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Washington, District Of Columbia, United States
Nashville, Tennessee, United States
Atlanta, Georgia, United States
Washington, District Of Columbia, United States
Bethesda, Maryland, United States
Rockville, Maryland, United States
Lackland Air Force Base, Texas, United States
San Antonio, Texas, United States
Patients applied
Trial Officials
Merigan TC
Study Chair
Mayers DL
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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