Pre-Exposure Prophylaxis of HIV-1 Infection
Conditions
Interventions
Emtricitabine/tenofovir alafenamide (coformulated
Descovy®) (F/TAF) and emtricitabine/tenofovir disoproxil fumarate (coformulated
Truvada®) (FTC/TDF) are 2 fixed-dose combinations (FDCs) used in the treatment and prevention of HIV. 
Sponsors
Gilead Sciences
Eligibility
Inclusion criteria
Inclusion criteria: All inclusion criteria from the iPrEx and DISCOVER studies apply (see protocol Appendix 5), except where superseded by the exclusion criteria listed below.Participants must have at least 1 record of measured body weight.
Exclusion criteria
Exclusion criteria: All exclusion criteria from the iPrEx and DISCOVER studies apply (see protocol Appendix 5).Transgender women recruited to the DISCOVER study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight outcomesIn both studies, participant body weight (in kg) was measured at baseline and at multiple visits up to 120 weeks after baseline. All available weight data measured on or following baseline will be used in this analysis with a limited exception: if participants had multiple distinct visit dates within the “baseline” window, only the chronologically last visit date prior to treatment will be retained. | — |
Secondary
| Measure | Time frame |
|---|---|
| CovariatesAvailable baseline demographics, clinical history, comorbidities, and other known factors prognostic for weight gain will be used. Participant comedications that may relate to weight change have been distilled from medication inventory files. If feasible, given recorded data, racial/ethnic group identity, and indicators of socioeconomic status like participant educational achievement may also be used as covariates. | — |
Countries
Austria, Brazil, Canada, Denmark, Ecuador, France, Germany, Ireland, Italy, Netherlands, Peru, South Africa, Spain, Thailand, United Kingdom, United States
Contacts
Public ContactGCSIC Gilead Clinical Study Information Center
Gilead Sciences
Outcome results
None listed