Table 2.

Study drug administration in the CAPRISA 018 trial assessing initial safety and dose escalation followed by an extended safety assessment

Study group (n)	Study drug	Estimated TAF implant daily drug release rate (mg/day)	Insertion site or oral	Duration of study drug exposure*
Group 1 (n=6)
1 (6)	TAF 110 mg implant	0.25	Arm	Up to 28 days
Group 2 (n=30)
2a (12)	TAF 110 mg implant	0.25	Arm	Approximately 24–48 weeks
2b (3)	Placebo implant	0	Arm	Approximately 24–48 weeks
2c (12)	2 TAF 110 mg implants	0.50 mg	One arm	Approximately 24–48 weeks
2d (3)	2 placebo implants	0	One arm	Approximately 24–48 weeks
Group 3 (n=24)
3a (6)	2 TAF 110 mg implants	0.50	One implant per arm	Up to 24 weeks
3b (6)	3 TAF 110 mg implants	0.75	One arm	Approximately 24–48 weeks
3c (6)	TAF 25 mg tablet	25	Oral	Up to 24 weeks
3d (6)	4 TAF 110 mg implants	1.0	One arm	Approximately 24–48 weeks
Group 4 (n=490)
4a (245)	TAF implant(s) plus placebo oral tablet	0.50 mg†	†Two TAF implants per arm plus oral placebo tablets	Approximately 48–120 weeks
4b (245)	TDF 300mg/FTC 200 mg oral tablet+placebo implant/s	0	†Two placebo implants per arm plus oral TDF/FTC tablets	Approximately 48–120 weeks

*Follow-up extended based on safety review of the adverse events occurring during the first 4 weeks after insertion in Groups 1–3.

†Based on the PK and safety assessment in dog models but is subject to change after PK data become available from Groups 1–3 in the trial.

FTC, emtricitabine; TAF, tenofovir alafenamide fumarate; TDF, tenofovir disoproxil fumarate.