HIV: Clinical Trials

Question 1

VIKING-3

Answer 1

Design: Single arm, failing regimen w/ RAL or EVG –> switched INSTI to DTG and after 8d of that added new backbone
Result: at 24wks 69% had VL<50 and there was a reduction in 8d Vl suggesting DTG had something to do with it

Question 2

STRATEGY-NNRTI

Answer 2

Design: suppressed adults on NNRTI + TDF/FTC; half changed to TDF/FTC/EVG/cobi
Results: EVG non-inferior

Question 3

STRATEGY-PI

Answer 3

Design: suppressed adults on PI + TDF/FTC; half changed to TDF/FTC/EVG/cobi
Results: EVG slightly superior due to stopping for non-virologic failure reasons

Question 4

FLAMINGO

Answer 4

Design: DRV vs. DTG in tx-naive
Results: DTG superior (due to stopping DRV for non-virologic failure reasons)

Question 5

SINGLE

Answer 5

Designs: ABC/3TC/DTG vs. TDF/FTC/EFV for tx-naive
Results: DTG regimen superior

Question 6

SAILING

Answer 6

Design: DTG vs. RTG for tx-experiences w/ 2 classes of mutations but no INSTI mutations
Results: DTG superior and w/ less resistance when failure

Question 7

SECOND-LINE

Answer 7

Design: RAL vs. LPV/r as second-line therapy
Results: RAL non-inferior

Question 8

SPRING-2

Answer 8

Design: RAL vs. DTG for second-line therapy
Results: DTG non-inferior

Question 9

EVG vs. RAL

Answer 9

Design: EVG vs. RTG for tx-experiences w/ 2 classes of mutations but no INSTI mutations
Results: EVG non-inferior

Question 10

Study 102

Answer 10

Design: TDF/FTC/EVG/cobi vs. TDF/FTC/EFV for tx-naive
Results: EVG non-inferior

Question 11

Study 103

Answer 11

Design: TDF/FTC/EVG/cobi vs. TDF/FTC, STV/r for tx-naive
Results: EVG non-inferior

Question 12

STARTMRK

Answer 12

Design: RAL vs. EFV for tx-naive
Results: RAL non-inferior, then at 5yrs was superior

Question 13

SWITCHMRK

Answer 13

Design: on LPV/r and randomized to continue or change to RAL
Results: RAL inferior

Question 14

STaR

Answer 14

Design: tx-naive given EFV vs. RPV
Results: RPV non-inferior but was superior if VL 100K

Question 15

PI/r switched to RPV

Answer 15

Design: 2/3 switched PI/r to RPV, 1/3 stayed on PI/r
Results: RPV non-inferior but had better lipid profile, VL >100K before tx didn’t affect outcome

Question 16

ECHO and THRIVE

Answer 16

Design: RPV vs. EFV for tx-naive (ECHO w/ TDF/FTC backbone, THRIVE w/ other backbones)
Results: RPV non-inferior but trend toward inferior although fewer ADRs)…later analysis showed more failure if VL>100K

Question 17

DUET 1 & 2

Answer 17

Design: ETV vs. placebo if failing therapy w/ NNRTI mutations to EFV/NVP and at least 3 PI mutations
Results: ETV superior to placebo

Question 18

ODIN

Answer 18

Design: tx-experienced with no DRV mutations randomized to daily or q12 DRV
Results: q12 non-inferior to daily

Question 19

ARTEMIS and TITAN

Answer 19

Design: DRV vs. LPV for tx-naive (ARTEMIS) or any tx-hx (TITAN)
Results: DRV superior with better side effect profile

Question 20

POWER 1 & 2

Answer 20

Design: tx-experienced got DRV vs. other PIs
Results: greater log reductions in VL on RVR than other PIs

Question 21

SWIFT

Answer 21

Design: on PI/r + ABC/3TC, randomized to stay or switch backbone to TDF/FTC
Results: TDF/FTC non-inferior w/ better lipid profile and worse CrCl

Question 22

ACTG 5202

Answer 22

Design: ABC/3TC vs. TDF/FTC w/ either ATV/r or EFV
Results: higher rate of failure w/ ABC/3TC (regardless of EFV or ATV/r), shorter time to failure w/ ABC/3TC if VL>100K

Question 23

ACTG 5257

Answer 23

Design: tx-naive given TDF/FTC with ATV/r vs. RAL vs. DRV/r
Results: equivalent virologic efficacy but combining tolerability w/ efficacy RAL was superior to both and DRV/r was superior to ATV/r (mainly due to hyperbilirubinemia)