A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001095|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Indinavir sulfate Drug: Amprenavir Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Zidovudine||Phase 2|
This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels ("treatment failures") the opportunity to change to a potentially more active regimen that includes indinavir, nevirapine, lamivudine, and stavudine.
Patients with HIV RNA less than 500 copies/ml on a regimen containing amprenavir are treated on Arm A; those with greater than or equal to 500 copies while on or intolerant to a regimen containing amprenavir are treated on Arm B.
Arm A: Amprenavir + ZDV + d4T + 3TC. Arm B: IND + NVP + 3TC + d4T. Patients enrolled in Arm A who fail therapy may roll over to Arm B. Patients in Arm B who fail therapy discontinue study medications and seek best available treatment.
[AS PER AMENDMENT 2/27/98: Patients with HIV RNA less than 500 copies/ml currently on triple therapy with amprenavir + 3TC + ZDV (or d4T if ZDV-intolerant) are treated on ARM A. Patients with HIV RNA greater than or equal to 500 copies/ml, who have been intolerant to a regimen containing amprenavir or who were previously enrolled on ACTG 347 who elected to receive a treatment regimen other than amprenavir + ZDV (or d4T) + 3TC or IDV + NVP + 3TC + d4T or other regimens are assigned to Arm C.
Arm A: Amprenavir + ZDV* plus 3TC. Arm B: IDV** + NVP + 3TC + d4T***. Arm C: Observation only. Patients are followed for the duration of the study.
- Patients intolerant of ZDV may elect to receive d4T. **Patients intolerant of IDV may take study-provided nelfinavir. ***Patients who switched to open-label IDV/NVP/3TC/d4T prior to enrollment on this study and who were intolerant to any of the study medications may enroll into Arm B with appropriate substitution of the intolerant study drug(s).
Patients initially assigned to Arm A who are intolerant of amprenavir or who fail therapy have the option of receiving Arm B therapy. Patients initially assigned to Arm B who are intolerant of any of the assigned study drugs may make an appropriate antiretroviral substitution (with approval of the protocol chair).]
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||94 participants|
|Official Title:||A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other Treatment Regimens (Observational ARM) in Subjects Previously Treated With Amprenavir|
|Actual Study Completion Date :||October 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001095
|United States, California|
|Univ of Southern California / LA County USC Med Ctr|
|Los Angeles, California, United States, 900331079|
|United States, Colorado|
|Univ of Colorado Health Sciences Ctr|
|Denver, Colorado, United States, 80262|
|United States, Florida|
|Univ of Miami School of Medicine|
|Miami, Florida, United States, 331361013|
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|United States, Illinois|
|Cook County Hosp|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Boston Med Ctr|
|Boston, Massachusetts, United States, 02118|
|Beth Israel Deaconess - West Campus|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|St Louis Regional Hosp / St Louis Regional Med Ctr|
|Saint Louis, Missouri, United States, 63112|
|United States, New York|
|Bellevue Hosp / New York Univ Med Ctr|
|New York, New York, United States, 10016|
|United States, North Carolina|
|Univ of North Carolina|
|Chapel Hill, North Carolina, United States, 275997215|
|United States, Pennsylvania|
|Univ of Pennsylvania at Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|West Columbia, South Carolina, United States, 29169|
|Study Chair:||Murphy R|
|Study Chair:||Gulick R|