Status:
COMPLETED
Bone and Body Comp: A Sub Study of the SECOND-LINE Study
Lead Sponsor:
Kirby Institute
Conditions:
HIV
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Second-Line main study identifier: NCT00931463
- HIV-1 positive by licensed diagnostic test
- Aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate)
- Have received first antiretroviral regimen consisting of an NNRTI plus 2N(t)RTIs for ≥ 24 weeks
- No change in antiretroviral therapy within 12 weeks prior to screening
- 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
- No prior or current exposure to HIV protease inhibitors and/or HIV integrase inhibitors
- Able to provide written informed consent
Exclusion
- 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
- Pregnant or nursing mothers
- Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
- Use of immunomodulators within 30 days prior to screening
- Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
- Intercurrent illness requiring hospitalisation
- Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
- Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
- Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01513122
Start Date
February 1 2010
End Date
August 1 2013
Last Update
June 26 2025
Active Locations (7)
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1
CEADI
Buenos Aires, Argentina
2
YRGCare Medical Centre
Chennai, India, 600113
3
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
4
JOSHA Research
Bloemfontein, South Africa