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An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine (3TC) and Stable (>= 4 Weeks) Background Nucleoside Therapy
To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
Drug Research and Analysis Corp
Montgomery, Alabama, United States
Dr G Michael Wool
Los Angeles, California, United States
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, United States
AIDS Research Ctr / Palo Alto VA Health Care System
Palo Alto, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
ViRx Inc
San Francisco, California, United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Infectious Disease Specialists
Colorado Springs, Colorado, United States
Denver Public Health
Denver, Colorado, United States
Last Updated
June 24, 2005
2,000
Estimated participants
Nevirapine
DRUG
Lamivudine
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330