Table 1.

Clinical Trial Data Sets for LA ARVs

Pre-Exposure Prophylaxis (PrEP)
Drug	Study ID	Study description	Comments/Status
CAB	NCT02178800	Phase IIa study designed to evaluate the safety, tolerability and pharmacokinetics of oral CAB and IM CAB LA as PrEP for HIV-1 negative adults.	Estimated study completion date is July 2017
	ÉCLAIR	Phase IIa study designed to evaluate safety, tolerability and acceptability of oral CAB and IM CAB LA for PrEP in HIV-1 negative adult males.	Both CAB and CAB LA were well tolerated Site of injection reactions were pain, swelling and itching The absorption and clearance rate of CAB LA was found to be faster than predicted by the PK models.
	CAPRISA 014	Phase IIa study designed to evaluate safety and acceptability of oral CAB and IM CAB LA for PrEP in HIV-1 negative women at high risk of being infected with HIV-1.	Estimated study completion date is September 2018
	NCT02720094	Phase IIb/III study designed to compare the safety and efficacy of IM CAB LA to daily oral tenofovir disoproxil fumarate/emtricitabine for PrEP in HIV-1 negative cisgender men and transgender women at high risk of being infected with HIV-1.	Estimated study completion date is June 2020
RPV LA	SSAT 040	Phase I study designed to evaluate the safety, pharmacokinetics and metabolism of various doses of IM RPV LA in low risk HIV-1 negative females.	All doses administered were well tolerated RPV was detectable in all samples through day 84. A single 300 mg dose of RPV LA was found not to be effective at providing protection against HIV-1 infection
	MWR1-01	Phase I study designed to evaluate the safety, acceptability, pharmacokinetics and ex-vivo pharmacodynamics of IM RPV LA in adults	Rectal tissue concentrations of RPV (five times above the therapeutic concentration) were found to be higher than concentrations in vaginal tissue (2.5 times below the therapeutic concentration). Significant suppression of viral replication by RPV LA was only seen in the rectal tissue
	HPTN 076	Phase II study designed to evaluate the safety and tolerability of IM RPV LA for PrEP in HIV-1 negative adult women	Estimated study completion date is 2017

HIV/AIDS Treatment
Drug	Study ID	Study description	Comments/Status
RPV LA & CAB LA	LATTE-2	Phase IIb study designed to compare the safety and efficacy of intramuscular two drug regimen of CAB LA + RPV LA with daily triple oral CAB+ABC/3TC in naïve adult patients.	At 32 weeks, antiviral activity of the two long acting injectable nano-suspensions was comparable to daily oral three-drug dose. Injection site reactions were noted