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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513122
First Posted: January 20, 2012
Last Update Posted: January 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kirby Institute
January 16, 2012
January 20, 2012
December 1, 2013
January 17, 2014
January 17, 2014
February 2010
September 2012   (Final data collection date for primary outcome measure)
  • Mean Bone Mineral Density Changes Over 48 Weeks as Measured by DXA Scan [ Time Frame: May 2013 ]
  • Mean Limbs Fat Changes Over 48 Weeks as Measured by DXA Scan [ Time Frame: May 2013 ]
Mean limb fat and bone mineral density changes as measured by DXA scan [ Time Frame: May 2013 ]
Complete list of historical versions of study NCT01513122 on ClinicalTrials.gov Archive Site
  • Mean Total Body Fat Changes Over 48 Weeks as Measured by DXA Scan [ Time Frame: May 2013 ]
  • Mean Triglycerides Changes Over 48 Weeks as Measured by DXA Scan [ Time Frame: May 2013 ]
  • Mean Total Cholesterol Changes Over 48 Weeks as Measured by DXA Scan [ Time Frame: May 2013 ]
  • Mean Glucose Changes Over 48 Weeks as Measured by DXA Scan [ Time Frame: May 2013 ]
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Bone and Body Comp: A Sub Study of the SECOND-LINE Study
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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).

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV
  • Drug: Lopinavir / ritonavir + 2-3N(t)RTI
    LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
  • Drug: Lopinavir /ritonavir + raltegravir
    LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
  • Active Comparator: Arm 1. Lopinavir / ritonavir + 2-3N(t)RTI
    Intervention: Drug: Lopinavir / ritonavir + 2-3N(t)RTI
  • Active Comparator: Arm 2. Lopinavir /ritonavir + raltegravir
    Intervention: Drug: Lopinavir /ritonavir + raltegravir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
August 2013
September 2012   (Final data collection date for primary outcome measure)

Second-Line main study identifier: NCT00931463

Inclusion Criteria:

  1. HIV-1 positive by licensed diagnostic test
  2. Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)
  3. Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for ≥ 24 weeks
  4. No change in antiretroviral therapy within 12 weeks prior to screening
  5. Failed first-line NNRTI + 2N(t)RTI combination therapy according to virological criteria defined by two consecutive (≥7 days apart) HIV RNA results of > 500 copies/mL
  6. No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors
  7. Able to provide written informed consent

Exclusion Criteria:

  1. The following laboratory variables:

    • absolute neutrophil count (ANC) < 500 cells/µL
    • hemoglobin < 7.0 g/dL
    • platelet count < 50,000 cells/µL
    • ALT > 5 x ULN
  2. Pregnant or nursing mothers
  3. Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
  4. Use of immunomodulators within 30 days prior to screening
  5. Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
  6. Intercurrent illness requiring hospitalisation
  7. Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
  8. Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
  9. Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   India,   Malaysia,   South Africa,   Thailand
 
 
NCT01513122
2L body comp sub-study
Yes
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Kirby Institute
Kirby Institute
Not Provided
Principal Investigator: Paddy Mallon Mater Misericordiae University Hospital, Dublin
Principal Investigator: Waldo Belloso Hospital Italiano, Argentina
Principal Investigator: Samuel Ferret Hopital Saint-Louis, France
Principal Investigator: Praphan Phanuphak HIV-NAT Program on AIDS - Thai Red Cross, Bangkok
Principal Investigator: Jennifer Hoy The Alfred
Kirby Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP