START (Strategic Timing of AntiRetroviral Treatment)
HIV–NAT 097
A Multicenter Study of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1 infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm3. The study will proceed in two phases: (1) a pilot phase, involving at least 900 participants; and (2) a definitive phase, expanding enrollment to an estimated 4,000 participants. Upon completion of the pilot phase, a recommendation will be made to the sponsor (DAIDS, NIAID, NIH) concerning whether the study should be expanded and prolonged into a definitive study. Successful completion of the pilot phase requires enrollment of at least 900 participants in one year by 70 designated INSIGHT sites. For Thailand, seven additional sites were included: Siriraj Hospital, San Patong Hospital, Chonburi Hospital, Chiangrai Prachanukroh Hospital, RIHES Chiang Mai University, Ramathibodi Hospital and Bamrasnaradura Infectious Disease Institute
The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1 infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm3. The study will proceed in two phases: (1) a pilot phase, involving at least 900 participants; and (2) a definitive phase, expanding enrollment to an estimated 4,000 participants. Upon completion of the pilot phase, a recommendation will be made to the sponsor (DAIDS, NIAID, NIH) concerning whether the study should be expanded and prolonged into a definitive study. Successful completion of the pilot phase requires enrollment of at least 900 participants in one year by 70 designated INSIGHT sites. For Thailand, seven additional sites were included: Siriraj Hospital, San Patong Hospital, Chonburi Hospital, Chiangrai Prachanukroh Hospital, RIHES Chiang Mai University, Ramathibodi Hospital and Bamrasnaradura Infectious Disease Institute
ENCORE1 (Evaluation of Novel Concepts in Optimization of antiRetroviral Efficacy)
HIV–NAT 128
A randomized, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose (400mg) efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naive HIV-infected individuals over 96 weeks. HIV-NAT is the Thai co-ordinating centre. There are three substudies: 1) CNS, 2) Intensive PK and 3) Neurocognitive substudy. Staff from HIV-NAT have initiated this last substudy and will be responsible for the data collection and sub-study analysis.
HIV-NAT 128.1
A randomised, double‐blind, placebo‐controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral‐naïve HIV‐infected individuals over 96 weeks Encore1 intensive pharmacokinetics sub-study
CNS substudy
HIV-NAT 128.2
A randomised, double‐blind, placebo‐controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral‐naïve HIV‐infected individuals over 96 weeks
Neurocognitive substudy
HIV-NAT 128.3
The neurocognitive sub-study in Encore1: A randomised, double‐blind, placebo‐controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral‐naïve HIV‐infected individuals over 96 weeks
SECONDLINE (A randomized open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2-3N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line NNRTI/2N(t)RTI therapy: the SECOND-LINE study)
HIV–NAT 119
This is a Phase IIIb/IV, international, randomized, open label study comparing two regimens of combination antiretroviral therapy in people living with HIV with confirmed virological failure of first-line NNRTI/2N(t)RTI regimens. The study runs for 96 weeks but the primary analysis takes place at the week 48.
LASA (Low dose Atazanavir/r vs. Standard dose Atazanavir/r)
HIV–NAT 110
A multicenter randomized study to compare the efficacy and safety of lower dose atazanavir/ritonavir (ATV/r 200/100 mg OD) versus standard dose (ATV/r 300/100 mg OD) in combination with 2NRTIs in well virology suppressed HIV-infected adults
LASA HAIR substudy
HIV-NAT 110.2
This study will evaluate the atazanavir/ritonavir concentration in hair
Feasibility Study (Test and Treat)
HIV-NAT 162
Trial to Evaluate the Acceptability and Feasibility of “Test and Treat” and “link-to-care” to reduce HIV transmission among men having sex with men in Bangkok
This cross-sectional study will evaluate the interest and attitudes on regular voluntary HIV counseling and testing, assess the acceptability of immediate antiretroviral therapy if seropositive and identify the associated factors in improving access to treatment and care. The information from this study will be used to design the upcoming Test and Treat Study.
© Copyright 2012 HIV-NAT. All Rights Reserved.
The HIV Netherlands Australia Thailand Research Collaboration