Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF)
Summary
Long-term side effects of antiretrovirals (ART) have led to the introduction in clinical practice of NRTI-sparing regimens as double- or mono- therapy and their use is now recommended in specific populations by International Guidelines. Indeed, based on the monitoring of surrogate markers of ART efficacy, most of these unconventional regimens, when used in switch studies, have shown to have a non-inferior virological efficacy and a good CD4 recovery compared to standard triple drug-based therapy. At present, the best marker to evaluate the risk of developing of non-AIDS related events has not been determined. Interestingly, the analysis of the data of the investigator's and others cohorts have shown that, in contrast with recent data from ART-CC collaboration, a low CD4/CD8 ratio is a predictor of non-AIDS related events independently from CD4 cell count, while other studies have shown an association of this marker with non-AIDS defining cancers or, more recently, with pulmonary emphysema. Aim of the present study is to compare CD8 and CD4/CD8 slopes in patients switching with an undetectable viral load to the 2 regimens which will be more frequently used in clinical practice: i.e B/F/TAF and dolutegravir + lamivudine. Indeed, B/F/TAF is already a recommended regimen in all guidelines while dolutegravir + lamivudine is widely used in clinical practice.
Timeline
- Start
- 2020-01-23
- Primary completion
- 2020-01-23
- Completion
- 2022-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dolutegravir | Other / unclassified | 50 mg | — |
| Comparator | Lamivudine | Other / unclassified | 300 mg | — |
| Subject | bictegravir | Small molecule | 50 mg | — |
| Subject | emtricitabine | Other / unclassified | 200 mg | — |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | — |