Table 1.
Characteristics of included studies.
| Study (author, year [trial name; NCT ID or Clinicaltrials.gov identifier]) | Phase | Masking | Location | Population characteristics | Design | Sample size, n | Age (years)a | Male, n (%) | |||||||||
| Prophylaxis | |||||||||||||||||
|
|
Landovitz et al [28], 2018 (HPTN 077; NCT02178800) | Ⅱa | Double-blind | Multicenter | Participants were HIV uninfected at screening and at low risk for HIV infection | CABb-LAc IMd 600 mg Q8We vs placebo | 89 (69If, 20Cg) | 31 (24-37) | 29 (33) | ||||||||
|
|
Landovitz et al [28], 2018 (HPTN 077; NCT02178800) | Ⅱa | Double-blind | Multicenter | Participants were HIV uninfected at screening and at low risk for HIV infection | CAB-LA IM 800 mg Q12Wh vs placebo | 110 (82I, 28C) | 33 (25-42) | 38 (35) | ||||||||
|
|
Markowitz et al [29], 2017 (ECLAIR; NCT02076178) | Ⅱa | Double-blind | Multicenter | Participants were male at birth, HIV uninfected, and reported having at least one casual se partner in the past 24 mo | CAB-LA IM 800 mg Q12W vs placebo | 127 (106I, 21C) | 31 (20-61) | 127 (100) | ||||||||
|
|
Spreen et al [30], 2014 (NCT01756131) | Ⅰ | Open-label | Single-center | Healthy volunteers | CAB-LA IM 100, 200, 200×2, 400, 400×2 mg single-dose vs placebo | 72 (58I, 14C) | 35.1 (10.4) | 39 (54.2) | ||||||||
|
|
Landovitz et al [31], 2021 (HPTN 083; NCT02720094) | Ⅱb-Ⅲ | Double-blind | Multicenter | Adults had a negative HIV serological test at enrollment and had an undetectable blood HIV RNA viral load within 14 days before trial entry | CAB-LA IM 600 mg Q8w with TDFi-FTCj placebo QDk vs TDF-FTC QD with CAB-LA placebo IM Q8w | 4570 (2283I, 2287C) | 26 (22-32) | 3992 (87.4) | ||||||||
|
|
Delany-Moretlwe et al [32], 2022 (HPTN 084; NCT03164564) | Ⅲ | Double-blind | Multicenter | Female reported at least 2 episodes of vaginal intercourse in the previous 30 days were at risk of HIV infection based on an HIV risk score | CAB-LA IM 600 mg Q8w with TDF-FTC placebo QD vs TDF-FTC QD with CAB-LA placebo IM Q8w | 3224 (1614I, 1610C) | 25 (22-30) | 0 (0) | ||||||||
|
|
Verloes et al [33] 2015, (NCT01031589) | Ⅰ | Open-label; double-blind | Single-center | Healthy volunteers | RPV-LA IM 300,600 mg single-dose; RPV-LA IM 1200 and 600 and 600 mg Q4wm vs placebo | 11; 8 (6I, 2C) | 47 (31-58); 47 (31-58) | 6 (31.6) | ||||||||
|
|
Bekker et al [34], 2020 (HPTN 076; NTC02165202) | Ⅱ | Double-blind | Multicenter | Healthy, sexually active, low-risk, HIV-uninfected women | RPVl-LA IM 1200 mg Q8W vs placebo | 136 (91I, 45C) | 31 (25-38) | 0 (0) | ||||||||
| Treatment | |||||||||||||||||
|
|
Margolis et al [35] 2017, (LATTE-2; NCT02120352) | Ⅱb | Open-label | Multicenter | Treatment-naive adults with HIV-1 who were given either CAB 30 mg POn+ABCo/3TCp 600/300 mg PO QD for 20 weeks and who had a VLq<50 copies/mL | CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W or CAB-LA IM 600 mg+RPV-LA IM 900 mg Q8W vs CAB PO 30 mg + ABC PO 600 mg + 3TC PO 300 mg QD | 286 (115I,115I, 56C) | 35 (19-64) | 262 (92) | ||||||||
|
|
Smith et al [36], 2021 (LATTE-2 extension phase; NCT02120352) | Ⅱb | Open-label | Multicenter | Adults completing 96 weeks of LATTE-2 enter an extension phase | CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W; CAB-LA IM 600 mg+RPV-LA IM 900 mg Q8W. Optimized loading dose (100 weeks) followed by CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W; Optimized loading dose (100 weeks and 104 weeks) followed by CAB-LA IM 600 mg+RPV-LA IM 900 mg Q8W | 115; 115; 10; 34 | 36 (19-62); 34 (20-64); 41 (21-56); 36 (19-56) | 109 (95); 107 (93); 8 (80); 28 (82) | ||||||||
|
|
Orkin et al [37], 2021 (FLAIR; NCT02938520) | Ⅲ | Open-label | Multicenter | Treatment-naive adults with HIV-1 who were given DTGq/ABC/3TC PO 50/600/300 mg QD for 20 weeks and who had a VL<50 copies/mL | CAB PO 30 mg+RPV PO 25 mg QD for 4 weeks, followed by CAB-LA; IM 600 mg+RPV-LA IM 900 mg, then CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W for 100 weeks vs DTG PO 50 mg + ABC PO 600 mg + 3TC PO 300 mg QD for 100 weeks | 566 (283I, 283C) | 34 (29-43) | 439 (78) | ||||||||
|
|
Orkin et al [38], 2021 (FLAIR extension phase; NCT02938520) | Ⅲ | Open-label | Multicenter | Adults completing 100 weeks of ATLAS enter an extension phase | Switched from CAB 30 mg+RPV 25 mg QD to CAB-LA+RPV-LA (direct-to-injection group); switched from CAB 30 mg+RPV 25 mg QD to CAB-LA+RPV-LA (oral lead-in group); continued the long-acting regimen | 111; 121; 283 | 36 (30-45); 38 (31-46); 34 (29-42) | 24 (22); 27 (22); 63 (22) | ||||||||
|
|
Swindells et al [39], 2020 (ATLAS; NCT02951052) | Ⅲ | Open-label | Multicenter | Adults with HIV-1 and had a VL<50 copies/mL for ≧6 months while taking PI-, NNRTI-, or INSTI-based regimen with a two-NRTI backbone | CAB 30 mg+RPV 25 mg QD for 4 weeks, followed by CAB-LA IM 600 mg+RPV-LA IM 900 mg, then CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W for 52 weeks vs PI-, NNRTI-, or INSTI-based QD for 52 weeks | 616 (308I, 308C) | 42 (18-82) | 413 (67) | ||||||||
|
|
Swindells et al [40], 2022 (ATLAS extension phase; NCT02951052) | Ⅲ | Open-label | Multicenter | Adults completing 52 weeks of ATLAS enter an extension phase | CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W vs switched from CAB 30 mg+RPV 25 mg QD to CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W | 52 (23, 29) | —r | — | ||||||||
|
|
Jaeger et al [41], 2021 (ATLAS-2M; NCT03299049) | Ⅲb | Open-label | Multicenter | Parents from ATLAS with a VL<50 copies/mL at screening and additional adults with HIV-1 and a VL<50 copies/mL for ≥6 months while taking standard oral ART | CAB-LA IM 400 mg+RPV-LA IM 600 mg Q4W; CAB-LA IM 600 mg+RPV-LA IM 900 mg Q8W | 523; 522 | 42 (34-50) | 765 (73) | ||||||||
|
|
Mills et al [42], 2021 (POLAR; NCT03639311) | Ⅱb | Open-label | Multicenter | Adults with HIV-1 who had a VL<50 copies/mL and completed at least 300 weeks of the LATTE study | CAB-LA IM 600 mg+RPV-LA IM 900 mg Q8W for 48 weeks vs DTG PO 50 mg + RPV PO 25 mg QD for 48 weeks | 97 (90I, 7C) | 41 (25-63) | 92 (94.8) | ||||||||
aUnless otherwise stated, age is presented as mean (SD) or median (IQR).
bCAB: cabotegravir.
cLA: long-acting.
dIM: intramuscular.
eQ8W: every 8 weeks.
fI: intervention group.
gC: control group.
hQ12W: every 12 weeks.
iTDF: tenofovir.
jFTC: emtricitabine.
kQD: daily.
lRPV: rilpivirine.
mQ4W: every 4 week.
nPO: per os.
qDTG: dolutegravir.
oABC: abacavir.
p3TC: lamivudine.
qVL: viral load.
rNot available.