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Integrase Inhibitor
Continue on non-integrase inhibitor based regimen for Vascular Disease
Phase 4
Waitlist Available
Led By Jonell B Poe, MPAS
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years with HIV-1 who have been virologically suppressed (HIV-1 RNA < 50 copies for greater than or equal to 3 months on a non-integrase strand transfer inhibitor-based regimen
Have the ability to understand and sign an informed consent written in the English language
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will compare the effects of two different HIV medication regimens on various health outcomes.
Eligible Conditions
- Vascular Disease
- HIV
- Antiviral Drug Reaction
- Weight Changes
- Obesity
- Lipodystrophy Syndrome
- Cardiovascular Abnormalities
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Weight
Secondary outcome measures
Change in body mass index (BMI)
Change in vascular endothelial function
Height
Other outcome measures
Change in HIV-1 RNA viral load
Change in cholesterol
Change in fasting serum glucose level
+4 moreTrial Design
2Treatment groups
Active Control
Group I: Continue on non-integrase inhibitor based regimenActive Control1 Intervention
Participants not currently on an integrase based regimen who remain on current suppressive therapy will remain on current antiretroviral regimen.
Group II: Switch from a non-integrase based regimen to dolutegravirActive Control1 Intervention
Participants with HIV-1 infection who have had viral suppression on a non-integrase based antiretroviral regimen for greater than or equal to 3 months will be switched to a dolutegravir based regimen dosed at 50 milligrams (MG) once daily. Background regimen will remain the same.
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
210 Previous Clinical Trials
85,046 Total Patients Enrolled
Jonell B Poe, MPASPrincipal InvestigatorAugusta University
Frequently Asked Questions
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