Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
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|ClinicalTrials.gov Identifier: NCT00021463|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 28, 2011
The purpose of this study is to learn whether changing from a type of anti-HIV drug called a protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of fats or sugars in the blood.
PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However, some people who take PIs have higher than normal levels of fats and/or sugars in the blood. Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the abnormal side effects. This study will test 3 different combinations of non-PI drugs to see which may improve side effects while keeping viral loads low.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Lipodystrophy||Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Abacavir sulfate Drug: Efavirenz Drug: Nevirapine||Phase 2|
Protease inhibitor (PI)-containing antiretroviral regimens are potent suppressors of HIV replication. Increasingly, metabolic abnormalities such as hypercholesterolemia and triglyceridemia are associated with PI use, reasons cited for switching to PI-sparing regimens. Yet optimal switch regimens that take into account both improvements in side effects and continued virologic suppression have not been defined. This study will compare the effect on chemical metabolic abnormalities of switching to an all nucleoside regimen versus dual nucleoside plus nonnucleoside reverse transcriptase inhibitor (NNRTI) therapy. Determining the effects of each regimen on chemical metabolic abnormalities and maintenance of virologic suppression will define which of the switch strategies being studied improves metabolic abnormalities without compromising viral suppression.
Patients are stratified on the basis of fasting non-HDL cholesterol and triglyceride levels and on ritonavir- or nonritonavir-containing pre-entry PI regimens. Patients are assigned randomly to add to their pre-entry regimen 1 of the following 3 treatments: Arm A - ABC; Arm B - NVP; or Arm C - EFV.
Patients discontinue pre-entry PIs after Day 14. Patients are followed to determine the effect of the maintenance regimens on fasting non-high-density lipoprotein (HDL), cholesterol, and triglycerides at Week 24. Fasting total cholesterol, HDL cholesterol, direct low-density lipoprotein, and triglycerides are measured at Weeks 12, 24, and 48. Fasting glucose, insulin, C-peptide, apolipoproteins A-1 and B, lipoprotein a, and homocysteine are measured at Weeks 24 and 48. Anthropometrics, body mass index, and body image are measured at Weeks 12, 24, and 48. HIV viral load is measured at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. If HIV RNA stays below 200 copies/ml, therapy continues unchanged. If confirmed HIV RNA of 200 copies/ml or higher is found, an HIV genotype is obtained providing the viral load is sufficient to yield results, the best medical therapy is instituted (not supplied by the study), and off treatment/on study follow-up is continued. If patients are intolerant to a study drug, an alternate study drug (ABC, EFV, or NVP supplied by the study) is permitted and switched treatment/on study follow-up continued, or the best medical therapy is instituted (not supplied by the study), and off treatment/on study follow-up is continued. Patients are followed until the last patient enrolled has completed 48 weeks on study.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||342 participants|
|Official Title:||Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities|
|Actual Primary Completion Date :||February 2002|
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): NCT00021463
|United States, Alabama|
|Univ of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, District of Columbia|
|Georgetown Univ Med Ctr|
|Washington, District of Columbia, United States, 20007|
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|United States, Illinois|
|Northwestern Univ Med School|
|Chicago, Illinois, United States, 60611|
|The CORE Ctr|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Boston Med Ctr|
|Boston, Massachusetts, United States, 02118|
|Brigham and Women's Hosp|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Beth Israel Med Ctr|
|New York, New York, United States, 10003|
|Bellevue Hosp / New York Univ Med Ctr|
|New York, New York, United States, 10016|
|United States, Pennsylvania|
|Univ of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Univ of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Chair:||David Wohl|