drugset / Trial / NCT02616783
Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.
Timeline
- Start
- 2015-12-22
- Primary completion
- 2018-02-21
- Completion
- 2018-03-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | E/C/F/TAF | Unknown | 10 mg | Oral |
| Subject | E/C/F/TAF | Unknown | 150 mg | Oral |
| Subject | E/C/F/TAF | Unknown | 200 mg | Oral |
| Comparator | FTC/TDF | Unknown | 200 mg | Oral |
| Comparator | FTC/TDF | Unknown | 300 mg | Oral |
| Comparator | TDF | Unknown | 300 mg | Oral |
| Comparator | Atazanavir | Other / unclassified | — | — |
| Comparator | Cobicistat | Small molecule | — | — |
| Comparator | Darunavir | Small molecule | — | — |
| Comparator | Dolutegravir | Other / unclassified | — | — |
| Comparator | Efavirenz | Other / unclassified | — | — |
| Comparator | Etravirine | Small molecule | — | — |
| Comparator | FTC | Unknown | 200 mg | Oral |
| Comparator | Fosamprenavir | Small molecule | — | — |
| Comparator | Lamivudine | Other / unclassified | — | Oral |
| Comparator | Lopinavir | Other / unclassified | — | — |
| Comparator | Nevirapine | Small molecule | — | — |
| Comparator | Raltegravir | Other / unclassified | — | — |
| Comparator | Rilpivirine | Small molecule | — | — |
| Comparator | Ritonavir | Other / unclassified | — | — |
| Comparator | Saquinavir | Small molecule | — | — |