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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
| IrsiCaixa | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 NRTI+ Dolutegravir | Experimental | 22 patients will be treated with 2 NRTI+Dolutegravir 50 mg during 24 weeks |
|
| 2 NRTI + PI | Active Comparator | 22 patients will be treated with 2 NRTI + PI during 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug |
| ||
| PI |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| C426859 | fosamprenavir |
| D000069446 | Atazanavir Sulfate |
| D061466 | Lopinavir |
| D000069454 | Darunavir |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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(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 |
|
|
| 2 NRTI | Drug |
|
| 2 NRTI | Drug |
|
|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |