Clinical Trials Flashcards
(23 cards)
CAMELIA TRIAL
prospective, randomized, multicenter, open-label superiority trial
Initiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower.
A5221 STRIDE
Earlier initiation of antiretroviral therapy (ART) in HIV-tuberculosis(TB) is associated with increased immune reconstitution inflammatory syndrome (IRIS). The severity, frequency and complications of TB IRIS were evaluated in A5221, a randomized trial of earlier ART (within 2 weeks after TB treatment initiation) vs. later ART (8-12 weeks after TB treatment) in HIV-infected patients starting TB treatment.
TB IRIS was more frequent with earlier ART initiation and CD4+ <50 cells/mm3.
COAT trial
RCT
Deferring ART for 5 weeks after the diagnosis of cryptococcal meningitis was associated with significantly improved survival, as compared with initiating ART at 1 to 2 weeks, especially among patients with a paucity of white cells in cerebrospinal fluid.
OLE & SALT studies
OLE - LPR/r + 3TC non interior to LP/r + XTC + NRTI
SALT - ATZ/r + 3TC non inferior to ATZ/r + 2NRTIs
MONCAY & DOMONGO studies
Dol monotgerapy - treatment failure
DONT USE DOL as monotherapy
ANDES study
DRV/r + 3TC non inferior to DRV/r + 3TC+ TDF
GEMINI studies
DTG/3TC non inferior to DTG+ TDF&3TC
Lower efficacy in VL > 100,000 & CD4 < 200 groups
No resistance
TANGO study
DTG/3TC to 48 weeks in switch from TAF based regimen- non inferior vs continuing on triple therapy
GS-1489 & GS-1490 studies
1489 - Biktarvy vs ABC/3TC/DTG
1490 - Biktarvy vs TAF/FTC/DTG
NON inferior
No resistance emerged
DRIVE studies
Doravirine studies
Higher genetic resistance barrier - activity against
K103N
Y181C
G190A
SWORD studies
DTG/RPV dual therapy non inferiority studies (switch studies)
Found to be non inferior
Injectable studies
CAB/RPV
LATTE 1& 2 - phase II
ATLAS & FLAIR - phase III
Virological failure noted in 2 subgroups on multivariate analysis:
- BMI > 30
- A1 and A6 subtype
Fostemsavir/BRIGHTE study
New drug for salvage therapy
Entry inhibitor - gp120 attachment inhibitor
Prodrug of temsavir- binds to gp120 and prevents viral ingress
BRIGHTE study - licensing study
CALIBRATE & CAPELLA studies
Lenacapavir - capsid inhibitor
OD or once a week!
CALIBRATE - oral or subcutaneous- NON inferior
CAPELLA - in patients with resistance & limited options
BUT LEN may have low barrier for resistance
REPRIEVE trial
RCT to prevent vascular events in HIV
> 40 years - received pitavastain vs no statin
35% reduction to CVD events at 5 years
Also looked at Abacavir - found to be associated with CVD events - 50% increased risk and ONLY ART to have a CVD events
PASO DOBLE study
Stable switch study to either Bijtarvy or Dovato (Dol/Lam)
Bijtarvy - increased weight gain noted (2nd gen INSTI + TAF thought to be responsible).
DOLCE study
Dovato in advanced HIV - low CD4 and ART naive patients
NON inferior to triple therapy!
PARTNER STUDY
Observational study in MSM that proved U=U
VL cut off used 200.
ACTG 5257 study
Phase 3 open label RCT
RAL & Dar/r superior to AZT/r contains regimens
Same NRTI backbone of truvada in all 3 arms.
ANCHOR study
Anal cancer/HSIL outcome research
RCT - precursor of anal cancer - wait & watch vs electrocautery
Result: Anal cancer prevented by intervention
START trial
RCT
proved starting ART irrespective of CD4 beneficial
PIVOT trial
Compare PI monotherapy vs TDR
RCT open label
Suppressed > 6 months were randomised to continue TDR vs PI monotherapy with prompt return to combination ART if rebound.
Result: PI monotherapy with prompt return non inferior.
IPREX study
RCT
Truvada vs placebo for PreP
Result: 44% reduction in acquisition. Even higher when drugs levels detectable in the subjects (some people who acquired HIV had no detectable drug levels).
