Study Stopped
Low enrollment
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
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
1 other identifier
interventional
4
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2014
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2013
CompletedFirst Posted
Study publicly available on registry
July 18, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedOctober 17, 2018
October 1, 2018
2.3 years
July 10, 2013
October 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variations from baseline in DEXA-measured bone mineral density (t-score, spine and femur)
48 weeks
Secondary Outcomes (2)
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
Other Outcomes (6)
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
- +3 more other outcomes
Study Arms (2)
raltegravir
EXPERIMENTALraltegravir and atazanavir and ritonavir
tenofovir/emtricitabine
ACTIVE COMPARATORtenofovir/emtricitabine and atazanavir and ritonavir
Interventions
switch tenofovir/emtricitabine to raltegravir
no change in antiretroviral treatment; patients will continue their regimen (tenofovir/emtricitabine and atazanavir and ritonavir)
Eligibility Criteria
You may qualify if:
- Adult HIV-positive female patients;
- osteopenia (t-score from -1 to -2.5);
- On antiretroviral treatment with tenofovir/emtricitabine and atazanavir/ritonavir (300/100 mg) for at least six months;
- Plasma HIV RNA below 50 copies/ml since six months;
- Premenopausal women: female patients at any phase of the reproductive period with regular menstrual cycles and normal FSH (\< 25 ng/mL) That would probably exclude patients with ovarian or endocrinological dysfunctions. Pre and postmenopausal should be therefore well-characterized.
- Women in menopausal period (the menopause was defined as 12 months of amenorrhoea without any pathological or physiological cause and using the endocrinological definition of ovary insufficiency (LH (Luteic hormone) \>25ng/mL, FSH (follicule stimulating hormone)\>25ng/mL and E2 (Estradiol)\<30ng/mL).
- Each premenopausal sexually active subject of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 3 months after stopping the medication.Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD (intrauterine device), inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation).
- Postmenopausal women are not required to use contraception.
You may not qualify if:
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- Documented resistance to Raltegravir or/and Atazanavir.
- Patient with significant hypersensitivity or other contraindication to any of the components of the study drugs.
- Patient has a current (active) diagnosis of acute hepatitis due to any cause
- Patient with coinfection HIV/HBV (Human Hepatitis virus B)
- Liver cirrhosis
- Osteoporosis (t-score less than 2.5).
- Secondary endocrinological cause of low BMD (Bone mineral density)
- Chronic steroid intake;
- Chronic kidney disease (estimated glomerular filtration rate below 60 ml/min);
- Concomitant use of bisphosphonate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Giovanni Di Perrilead
- University of Turin, Italycollaborator
- University of Milancollaborator
Study Sites (2)
University of Milano
Milan, Italy
University of Torino
Torino, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Di Perri, MD, PhD
University of Turin, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Full professor of Infectious Diseases
Study Record Dates
First Submitted
July 10, 2013
First Posted
July 18, 2013
Study Start
September 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
October 17, 2018
Record last verified: 2018-10