Lopinavir/Ritonavir Monotherapy after 24 Weeks of Second-Line Antiretroviral Therapy in Africa: A Randomized Controlled Trial (Sara)

Background Boosted protease inhibitor (bPI) monotherapy (bPImono) potentially has substantial cost, safety and operational benefits. It has never been evaluated as second-line antiretroviral therapy (ART) in Africa. Methods After 24 weeks of lopinavir/ritonavir- containing second-line therapy, DART...

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Bibliographic Details
Published in:Antiviral therapy 2012-01, Vol.17 (7), p.1363-1373
Main Authors: Gilks, Charles F, Walker, A Sarah, Dunn, David T, Gibb, Diana M, Kikaire, Ben, Reid, Andrew, Musana, Hellen, Mambule, Ivan, Kasirye, Ronnie, Robertson, Val, Ssali, Francis, Spyer, Moira, Pillay, Deenan, Yirrell, David, Kaleebu, Pontiano
Format: Article
Language:English
Subjects:
Adult
Africa
Antibiotics. Antiinfectious agents. Antiparasitic agents
antiretroviral therapy
Antiviral agents
Biological and medical sciences
CD4 antigen
CD4 Lymphocyte Count
Drug Resistance, Viral
Drug Therapy, Combination
Female
HIV - pathogenicity
HIV Infections - drug therapy
HIV Infections - pathology
HIV Infections - virology
HIV Protease Inhibitors - adverse effects
HIV Protease Inhibitors - therapeutic use
Human viral diseases
Humans
Immunodeficiencies
Immunodeficiencies. Immunoglobulinopathies
Immunopathology
Infectious diseases
Joints
Lopinavir
Lopinavir - adverse effects
Lopinavir - therapeutic use
Lymphocytes T
Male
Medical sciences
Middle Aged
Mutation
nucleoside reverse transcriptase inhibitors
Pharmacology. Drug treatments
Proteinase inhibitors
Ritonavir
Ritonavir - adverse effects
Ritonavir - therapeutic use
RNA, Viral - blood
Time Factors
Treatment Outcome
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Viral Load
Viremia
Viremia - pathology
Viremia - virology
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Summary:Background Boosted protease inhibitor (bPI) monotherapy (bPImono) potentially has substantial cost, safety and operational benefits. It has never been evaluated as second-line antiretroviral therapy (ART) in Africa. Methods After 24 weeks of lopinavir/ritonavir- containing second-line therapy, DART participants were randomized to remain on combination therapy (CT), or change to bPI-mono maintenance (SARA trial; ISRCTN53817258). Joint primary end points were CD4+ T-cell changes 24 weeks later and serious adverse events (SAEs); retrospectively assayed viral load (VL) was a secondary end point. Analyses were intention-to-treat. Results A total of 192 participants were randomized to CT (n=95) or bPImono (n=97) and followed for median 60 weeks (IQR 45–84). Participants received median 4.0 years (IQR 3.5–4.4) first-line ART. Median CD4+ T-cell count at first-line failure was 86 cells/mm3 (47–136), increasing to 245 cells/mm3 (173–325) after 24-week induction when 77% had VL
ISSN:1359-6535
2040-2058
DOI:10.3851/IMP2253