Bone and Body Comp: A Sub Study of the SECOND-LINE Study

Summary

The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis are also common in HIV-infected patients. There appears to be some association between ART and bone loss, but this is poorly understood and requires further research. The SECOND-LINE study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently standard of care. This study also provides an opportunity to examine if additional bone loss occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART used in second line therapy result in more or less bone loss than use of other classes of anti-HIV drugs such as protease inhibitors or N(t)RTI combinations.

It is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater increases in limb fat and smaller reductions in bone density at the proximal femur over 48 weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs).

Conditions

• HIV

Interventions

DRUG

Lopinavir / ritonavir

LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily

DRUG

2-3N(t)RTI

DRUG

raltegravir

raltegravir 400mg 1 tablet twice daily.

Sponsors & Collaborators

• Kirby Institute

  lead OTHER_GOV

Principal Investigators

• Paddy Mallon · Mater Misericordiae University Hospital, Dublin

• Waldo Belloso · Hospital Italiano, Argentina

• Samuel Ferret · Hopital Saint-Louis, France

• Praphan Phanuphak · HIV-NAT Program on AIDS - Thai Red Cross, Bangkok

• Jennifer Hoy · The Alfred

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2012-09-30

Completion

2013-08-31

Countries

• Argentina
• India
• Malaysia
• South Africa
• Thailand

Study Locations