Low enrollment
RALBAT
Switching HIV-positive Women on Tenofovir/Emtricitabine Plus Boosted Atazanavir to RALtegravir Plus Boosted ATazanavir: A Pilot Randomized Clinical Trial Investigating 48-weeks Changes in Bone Mineral Density
Sponsor study identifier
interventional
4
1 country
2
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2013
Actual (reported)July 18, 2013
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 2016
Actual (reported)December 2016
Actual (reported)Variations from baseline in DEXA-measured bone mineral density (t-score, spine and femur)
48 weeks
variations from baseline in CTX (C-terminal telopeptide of type I collagen) and OC (Osteocalcin)
24 and 48 weeks
To assess the variation in renal function
48 weeks
Cholesterol changes at 48 weeks in the two arms
48 weeks
Triglycerides changes in the two arms
48 weeks
Glucose Fasting Levels changes in the two arms
48 weeks
raltegravir and atazanavir and ritonavir
tenofovir/emtricitabine and atazanavir and ritonavir
switch tenofovir/emtricitabine to raltegravir
no change in antiretroviral treatment; patients will continue their regimen (tenofovir/emtricitabine and atazanavir and ritonavir)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
raltegravir and atazanavir and ritonavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
tenofovir/emtricitabine and atazanavir and ritonavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversity of Milano
Milan, Italy
University of Torino
Torino, Italy
Giovanni Di Perri, MD, PhD
University of Turin, Italy
4 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2013
First Posted
July 18, 2013
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
October 17, 2018
Record last verified: 2018-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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