drugset / Trial / NCT01902186
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
Phase 4
Terminated
4 enrolled
Giovanni Di Perri
University of Milan · collabUniversity of Turin, Italy · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Given the high prevalence of bone alteration in the course of HIV infection or antiretroviral treatment and the favourable properties of raltegravir the investigators designed this pilot randomized and controlled study. Adult female HIV-positive patients on successful treatment with tenofovir/emtricitabine plus atazanavir plus ritonavir will be randomized either to continue such a regimen or to switch to raltegravir plus atazanavir plus ritonavir. Bone mineral density changes will be compared in the two groups at 48 weeks: the hypothesis is that removing tenofovir and using tenofovir will increase bone mineral density at 48 weeks.
Timeline
- Start
- 2014-09
- Primary completion
- 2016-12
- Completion
- 2016-12
Outcome
Outcome not reported
Stopped (Enrollment): “Low enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Raltegravir | Other / unclassified | — | — |
| Comparator | Tenofovir | Small molecule | — | — |
| Comparator | emtricitabine | Other / unclassified | — | — |
| Background | Atazanavir | Other / unclassified | — | — |
| Background | Ritonavir | Other / unclassified | — | — |