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

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.
 
ClinicalTrials.gov Identifier: NCT01513122
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : January 17, 2014
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief 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).


Condition or disease Intervention/treatment Phase
HIV Drug: Lopinavir / ritonavir Drug: 2-3N(t)RTI Drug: raltegravir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone and Body Comp: A Sub Study of the SECOND-LINE Study
Study Start Date : February 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Arm 1. Lopinavir / ritonavir + 2-3N(t)RTI
LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTI
Drug: Lopinavir / ritonavir
LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily

Drug: 2-3N(t)RTI
Active Comparator: Arm 2. Lopinavir /ritonavir + raltegravir Drug: Lopinavir / ritonavir
LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily

Drug: raltegravir
raltegravir 400mg 1 tablet twice daily.




Primary Outcome Measures :
  1. Mean Bone Mineral Density Changes From Baseline to 48 Weeks as Measured by DXA Scan [ Time Frame: 48 weeks ]
  2. Mean Limbs Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Mean Total Body Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan [ Time Frame: 48 weeks ]
  2. Mean Triglycerides Changes From Baseline to 48 Weeks [ Time Frame: 48 weeks ]
  3. Mean Total Cholesterol Changes From Baseline to 48 Weeks [ Time Frame: 48 weeks ]
  4. Mean Glucose Changes From Baseline to 48 Weeks [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513122


Locations
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Argentina
CEADI
Buenos Aires, Argentina
India
YRGCare Medical Centre
Chennai, India, 600113
Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
South Africa
JOSHA Research
Bloemfontein, South Africa
Desmond Tutu HIV Foundation
Cape Town, South Africa, 7925
Chris Hani Baragwanath Hospital
Soweto, South Africa
Thailand
HIV-NAT Program on AIDS - Thai Red Cross
Bangkok, Thailand, 10330
Sponsors and Collaborators
Kirby Institute
Investigators
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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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01513122    
Other Study ID Numbers: 2L body comp sub-study
First Posted: January 20, 2012    Key Record Dates
Results First Posted: January 17, 2014
Last Update Posted: September 4, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Ritonavir
Lopinavir
Raltegravir Potassium
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors