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Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir

NCT01902186 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-10-17

No results posted yet for this study

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.

Conditions

  • HIV Infection
  • Osteopenia

Interventions

DRUG

raltegravir and atazanavir and ritonavir

switch tenofovir/emtricitabine to raltegravir

DRUG

tenofovir/emtricitabine and atazanavir and ritonavir

no change in antiretroviral treatment; patients will continue their regimen (tenofovir/emtricitabine and atazanavir and ritonavir)

Sponsors & Collaborators

  • University of Turin, Italy

    collaborator OTHER

  • University of Milan

    collaborator OTHER

  • Giovanni Di Perri

    lead OTHER

Principal Investigators

  • Giovanni Di Perri, MD, PhD · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01902186 on ClinicalTrials.gov