HIV InfectionPhase 4RALBATNCT01902186

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

A Phase 4 study testing raltegravir and atazanavir and ritonavir and tenofovir/emtricitabine and atazanavir and ritonavir in people with HIV Infection and Osteopenia, run by Giovanni Di Perri at 2 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: HIV Infection, Osteopenia
What is being tested?: raltegravir and atazanavir and ritonavir and tenofovir/emtricitabine and atazanavir and ritonavir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 2 sitesItaly
Study dates: Sep 2014to Dec 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

University of Milano
Milan
University of Torino
Torino

Other trials in Italy

About this study

Official title: 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

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.

Read the detailed description

The objective is to assess the improvement in Bone Mineral Density and markers of bone turnover in women on TDF/FTC (tenofovir disoproxil fumarate/ emtricitabine)+ ATV/r (atazanavir/ritonavir) in a switch arm (RAL (raltegravir) + ATV/r) vs. an unchanged arm (TDF/FTC + ATV/r).

The clinical hypothesis is that removing tenofovir (associated to a boosted PI, and therefore in the worst clinical scenario) in both pre-menopausal and menopausal women could be beneficial and being associated with reduced bone mineral density loss measured by DEXA (densitometry)scan scores and markers of bone turnover. The underlying mechanism is believed to be the reduction in hyper-phosphaturia induced by proximal tubular dysfunction: therefore measuring renal tubular markers and hormones involved in calcium and phosphorus homeostasis (such as vitamin D and parathormone) will explain the suspected mechanism.

Conditions: HIV Infection, Osteopenia
Being tested: raltegravir and atazanavir and ritonavir, tenofovir/emtricitabine and atazanavir and ritonavir
Keywords: HIV, osteopenia, t-score, DEXA, tenofovir, raltegravir
Medical subject headings: HIV Infections, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

raltegravir and atazanavir and ritonavirDrug
Also called Isentress (raltegravir), Reyataz (atazanavir), Norvir (ritonavir)
switch tenofovir/emtricitabine to raltegravir
tenofovir/emtricitabine and atazanavir and ritonavirDrug
Also called tenofovir/emtricitabine (Truvada), atazanavir (Reyataz), ritonavir (norvir)
no change in antiretroviral treatment; patients will continue their regimen (tenofovir/emtricitabine and atazanavir and ritonavir)

Study groups in NCT01902186
Study group	Role	What they receive
raltegravir	Experimental	raltegravir and atazanavir and ritonavir Receives: Drug: raltegravir and atazanavir and ritonavir
tenofovir/emtricitabine	Active comparator	tenofovir/emtricitabine and atazanavir and ritonavir Receives: Drug: tenofovir/emtricitabine and atazanavir and ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

Variations from baseline in DEXA-measured bone mineral density (t-score, spine and femur)
Measured: 48 weeks

Secondary outcomes (2)

variations from baseline in CTX (C-terminal telopeptide of type I collagen) and OC (Osteocalcin)
Measured: 24 and 48 weeks
To assess the variation in renal function
glomerular filtration rate, urinary markers of tubular dysfunction (nondiabetic glucosuria, altered resorption of phosphorus, hyperaminoaciduria, b2-micro-globuline excretion and abnormal uric acid excretion.) and urinary retinol binding protein
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Dec 2016

First posted18 Jul 2013 (estimated)
Study startSep 2014
Primary completionDec 2016
Study completionDec 2016

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01902186
Sponsor's protocol ID: RALBAT
Acronym: RALBAT
Status last verified: Oct 2018
First submitted: 10 Jul 2013
Last updated: 17 Oct 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01902186
Acronym / sponsor ID: RALBAT / RALBAT
Conditions: HIV Infection, Osteopenia
Keywords: HIV, osteopenia, t-score, DEXA, tenofovir, raltegravir
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 4 participants (actual)
Lead sponsor: Giovanni Di PerriUniversity, hospital or other
Collaborators: University of Turin, Italy, University of Milan
Study start: Sep 2014
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 18 Jul 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
raltegravir	Experimental	Drug: raltegravir and atazanavir and ritonavirraltegravir and atazanavir and ritonavir
tenofovir/emtricitabine	Active comparator	Drug: tenofovir/emtricitabine and atazanavir and ritonavirtenofovir/emtricitabine and atazanavir and ritonavir

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
raltegravir and atazanavir and ritonavirAlso: Isentress (raltegravir), Reyataz (atazanavir), Norvir (ritonavir)switch tenofovir/emtricitabine to raltegravir	Drug	raltegravir
tenofovir/emtricitabine and atazanavir and ritonavirAlso: tenofovir/emtricitabine (Truvada), atazanavir (Reyataz), ritonavir (norvir)no change in antiretroviral treatment; patients will continue their regimen (tenofovir/emtricitabine and atazanavir and ritonavir)	Drug	tenofovir/emtricitabine

Primary outcome

Variations from baseline in DEXA-measured bone mineral density (t-score, spine and femur)
Time frame: 48 weeks

2 secondary outcomes

variations from baseline in CTX (C-terminal telopeptide of type I collagen) and OC (Osteocalcin)
Time frame: 24 and 48 weeks
To assess the variation in renal function
Time frame: 48 weeks

Results and safety

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.

Related trials for HIV Infection

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A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giovanni Di Perri, MD, PhD principal investigator

University of Turin, Italy

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variations from baseline in DEXA-measured bone mineral density (t-score, spine and femur) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01902186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.