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Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable regimen on the long-term. However this regimen comprises 2 pills per day. Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP) of high potency, higher genetic barrier to resistance, with a very good safety profile. The objective of this study is to evaluate the virologic safety (maintenance of virologic suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory safety. Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK) assessment will be performed in all patients in the first weeks after switch and 24-hours PK in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching to ABC/3TC/DTG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abacavir/Lamivudine/Dolutegravir | Experimental | Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abacavir/Lamivudine/Dolutegravir | Drug | At Day 1 (D1):
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24 | Week 24 | |
| Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48 | Week 48 | |
| Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François RAFFI, Pr | Nantes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Roche-sur-Yon Hospital | La Roche-sur-Yon | France | ||||
| Nantes University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26271944 | Derived | Dailly E, Allavena C, Gregoire M, Reliquet V, Bouquie R, Billaud E, Hernando H, Bouchez S, Deslandes G, Hall N, Jolliet P, Raffi F. Influence of nevirapine administration on the pharmacokinetics of dolutegravir in patients infected with HIV-1. J Antimicrob Chemother. 2015 Dec;70(12):3307-10. doi: 10.1093/jac/dkv245. Epub 2015 Aug 13. |
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| Week 12 |
| Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24 | Week 24 |
| Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W36 | Week 36 |
| Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48 | Week 48 |
| Percentage of patients with adverse event of any Grade over 12 weeks | Week 12 |
| Percentage of patients with adverse event of Grade 3 or 4 over 48 weeks | Week 48 |
| CD4 and CD8 measurement | Changes in CD4 and CD8 counts over 48 weeks | Week 48 |
| Serum creatinine and GFR (MDRD) measurement | Changes in serum creatinine, and GFR (MDRD) from W2 to W48 | Week 48 |
| Urinary albumine:creatinine ratio measurement | Change in urinary albumine:creatinine ratio over 48 weeks | Week 48 |
| Fasting lipids measurement | Changes in fasting lipids over 48 weeks | Week 48 |
| Plasma concentration of NVP between Week 0 (W0) and Week 2 (W2) | The mean plasma concentration of nevirapine is measured between W0 and W2 (D0, W1, W2) | Week 2 |
| Plasma concentration of dolutegravir between W0 and W12 | The mean plasma concentration of dolutegravir is measured between W0 and W12 (W1, W2, W4, W12) | Week 12 |
| CD14 and usCRP measurement over 48 weeks | Changes in sCD14 and usCRP over 48 weeks (stored plasma) | Week 48 |
| Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires | Patient's satisfaction, evaluated with self-administered questionnaires HIVTSQs and HIVTSQc | Week 48 |
| Plasma concentration of DTG on 24h at D0 and Week 2 | 24h PK parameters of DTG (D0, after 5 days of combination of ABC/3TC + NVP + DTG) with and without NVP (D14) | Week 2 |
| Nantes |
| France |
| ID | Term |
|---|---|
| C000631408 | abacavir, dolutegravir, and lamivudine drug combination |
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