Status:
COMPLETED
A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Abbott
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will of...
Detailed Description
In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and ralt...
Eligibility Criteria
Inclusion
- 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 at least 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 (at least 7 days apart) HIV RNA results of greater then 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/microlitres
- hemoglobin \< 7.0 g/decilitres
- platelet count \< 50,000 cells/microlitres
- ALT great than 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 hospitalization
- 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 :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT00931463
Start Date
September 1 2009
End Date
August 1 2013
Last Update
September 4 2019
Active Locations (44)
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1
Hospital Interzonal General de Agudos, Oscar Alende
Buenos Aires, Mar Del Plata Provincia, Argentina, 1900
2
CAICI
Buenos Aires, Rosario Provincia de Sante Fe, Argentina, 2000
3
Hospital General de Agudos 'Teodoro Alvarez'
Buenos Aires, Argentina, 1406
4
FUNCEI
Buenos Aires, Argentina