Switch from tenofovir/emtricitabine to raltegravir in female HIV-positive patients taking atazanavir/ritonavir evaluating bone mineral density improvement after one year.
- Conditions
- HIV infection, osteopeniaTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-002349-12-IT
- Lead Sponsor
- nit of Infectious Diseases, Department of Medical Scieces, University of Torino c/o ASLTO2, Amedeo di Savoia Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 66
•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 esclude 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>25ng/mL, FSH>25ng/mL and E2<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, 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
•Liver cirrhosis
•Osteoporosis (t-score less than 2.5).
•Secondary endocrinological cause of low BMD
•Chronic steroid intake;
•Chronic kidney disease (estimated glomerular filtration rate below 60 ml/min*24h);
•Concomitant use of bisphosphonate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method