Effect of the HIV Protease Inhibitors Atazanavir and Lopinavir/Ritonavir on Cardiovascular Disease Risk Factors
Effect of HIV-1 Protease Inhibitors on Endothelial Function and Glucose Metabolism in Normal, HIV-Uninfected Subjects: Atazanavir or Lopinavir/Ritonavir or Placebo
3 other identifiers
interventional
30
1 country
1
Brief Summary
HIV protease inhibitors (PIs) are a class of antiretroviral drugs used to inhibit viral replication. They do so by interfering with a key step in the replication process. Some HIV PIs have been associated with an increased risk of adverse cardiovascular side effects. Further study is needed, however, to assess the full extent of effect of newer HIV PIs, including atazanavir and lopinavir/ritonavir, on cardiovascular disease risk. This study will compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular disease risk factors in healthy people without HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2003
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 21, 2008
CompletedFirst Posted
Study publicly available on registry
July 23, 2008
CompletedOctober 25, 2017
July 1, 2008
2.8 years
July 21, 2008
October 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Leg blood flow response to the intra-femoral artery infusion of methacholine chloride
Measured at Week 4
Secondary Outcomes (1)
Insulin sensitivity measured by the hyperinsulinemic euglycemic clamp study
Measured at Week 4
Study Arms (3)
1
EXPERIMENTALParticipants will receive treatment with atazanavir and placebo lopinavir/ritonavir.
2
EXPERIMENTALParticipants will receive treatment with lopinavir/ritonavir and placebo atazanavir.
3
PLACEBO COMPARATORParticipants will receive treatment with placebos for both drugs.
Interventions
400 mg/100 mg of lopinavir/ritonavir (three soft-gel capsules, each containing 133.3 mg lopinavir and 33.3 mg ritonavir) twice per day with food for 4 weeks
Eligibility Criteria
You may qualify if:
- Healthy and lean with normal lipids
- Not infected with HIV or viral hepatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Dube MP, Shen C, Greenwald M, Mather KJ. No impairment of endothelial function or insulin sensitivity with 4 weeks of the HIV protease inhibitors atazanavir or lopinavir-ritonavir in healthy subjects without HIV infection: a placebo-controlled trial. Clin Infect Dis. 2008 Aug 15;47(4):567-74. doi: 10.1086/590154.
PMID: 18636958RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael P. Dubé, MD
Indiana University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2008
First Posted
July 23, 2008
Study Start
November 1, 2003
Primary Completion
September 1, 2006
Study Completion
October 1, 2006
Last Updated
October 25, 2017
Record last verified: 2008-07