Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA
2 other identifiers
interventional
300
2 countries
59
Brief Summary
To validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine (AZT). To determine whether alternative regimens of antiretroviral agents alter the course of viral burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To obtain further data on the safety and immunologic and virologic response to AZT/didanosine/nevirapine. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
October 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +4 more criteria
You may not qualify if:
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Bristol-Myers Squibbcollaborator
- Glaxo Wellcomecollaborator
Study Sites (59)
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037, United States
Walter Reed Army Med Ctr
Washington D.C., District of Columbia, 20307, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225, United States
Queens Med Ctr
Honolulu, Hawaii, 96816, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Natl Naval Med Ctr
Bethesda, Maryland, 208995000, United States
Fitzsimmons Army Med Ctr
Rockville, Maryland, 20850, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479, United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479, United States
Mid - Hudson Care Ctr
Albany, New York, 122083479, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Columbia Presbyterian Med Ctr
New York, New York, 100323784, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY / State Univ of New York
Syracuse, New York, 13210, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, United States
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203, United States
Wake County Dept of Health
Raleigh, North Carolina, 27610, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Med College of Ohio
Toledo, Ohio, 43699, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Wilford Hall Med Ctr
Lackland Air Force Base, Texas, 782365300, United States
Brooke Army Med Ctr
San Antonio, Texas, 78284, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956, Puerto Rico
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (3)
Slade DE, Vavro CL, Stapleton JT, Swack N, StClair MH. A novel mutation at codon 215 of HIV RT. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0625)
BACKGROUNDMayers D, Merigan T, Gilbert P. T215Y/F mutation associated with zidovudine (ZDV) resistance leads to poor response to ZDV+ddI or ZDV+ddI+NVP: ACTG244/RV79. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:91 (abstract no 129)
BACKGROUNDHolodniy M, Katzenstein D, Mole L, Winters M, Merigan T. Human immunodeficiency virus reverse transcriptase codon 215 mutations diminish virologic response to didanosine-zidovudine therapy in subjects with non-syncytium-inducing phenotype. J Infect Dis. 1996 Oct;174(4):854-7. doi: 10.1093/infdis/174.4.854.
PMID: 8843229BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Merigan TC
- STUDY CHAIR
Mayers DL