HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen
Study Details
Study Description
Brief Summary
The purpose of this study is to assess changes in viral reservoir after changing IP/r to dolutegravir in HIV-1 infected patients maintaining undetectable viral load on Antiretroviral Therapy (ART).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 2 NRTI+ Dolutegravir 22 patients will be treated with 2 NRTI+Dolutegravir 50 mg during 24 weeks |
Drug: Dolutegravir
Drug: 2 NRTI
|
| Active Comparator: 2 NRTI + PI 22 patients will be treated with 2 NRTI + PI during 24 weeks |
Drug: PI
(Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir,if the 2 NRTIs are abacavir + Lamivudine
Other Names:
Drug: 2 NRTI
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 1 of the study compared to day 0 [1 week]
- Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 2 of the study compared to day 0 [2 weeks]
- Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 4 of the study compared to day 0 [4 weeks]
- Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 12 of the study compared to day 0 [12 weeks]
- Changes in mean of Long Terminal repeat (2LTR) in lymphocytes T Cluster of Differentiation 4+ (CD4 +) in peripheral blood obtained at week 24 of the study compared to day 0 [24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients infected with HIV-1
-
HIV RNA <50 copies / mL for ≥ 1 year with stable ART regimen (≥ 3 months) based on 2 NRTI and PI (Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir, if the 2 NRTIs are abacavir + Lamivudine
-
CD4 + lymphocytes > 200 / mm3
-
Signature of voluntary informed consent
-
A woman may be eligible to enter and participate in the study if:
-
No reproductive potential-defined as post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of getting pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
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It is in childbearing age with a negative pregnancy test on the day of screening and on Day 1 and agrees to use one of the following contraceptive methods to prevent pregnancy:
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Complete abstinence from penis-vaginal from 2 weeks prior to administration of investigational product, throughout the study, and for at least 2 weeks after discontinuation of all study drugs;
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Double barrier method (male / spermicidal condom, male condom / diaphragm, diaphragm / spermicide);
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Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion)
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Male sterilization confirmed before the entry of the female subject in the study, and that this man is the only sexual partner for women
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Approved hormonal contraception
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Any other method with published data show that the expected failure rate is <1% per year.
Exclusion Criteria:
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Prior virologic failure with an integrase inhibitor
-
Acquired Immune Deficiency Syndrome (AIDS)-defining illness in the last 48 weeks
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Glomerular filtration rate <50 mL / min, estimated by Chronic Kidney Disease Epidemiology (CKD-EPI) formula
-
Alanine aminotransferase (ALT) ≥5 times the Upper Limit Normal (ULN) or ALT ≥3 X ULN and total bilirubin ≥1,5 ULN (with> 35% direct bilirubin) and / or unstable liver disease (with the presence of ascites, hepatic encephalopathy, hypoalbuminemia, esophageal varices or persistent jaundice) or known biliary disorders excluded Gilbert syndrome or asymptomatic lithiasis) .
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Positive for hepatitis B (HBsAg +) or need for Hepatitis C Virus (HCV) treatment during the study .
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Subjects with severe hepatic impairment (Child Pugh Class C).
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Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol
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Pregnant or breast-feeding
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History or presence of allergy to any of the study drugs or their components
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 |
Sponsors and Collaborators
- Hospital Universitari Vall d'Hebron Research Institute
- University Hospital, Ghent
- IrsiCaixa
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INDOOR