Table 1.

Some of the promising intravaginal microbicides in development or holding promise for clinical trials [158, 315–322]

Delivery vehicle	API delivered	Purpose	Status	Description and outcome
Gel	TFV 1 %	Efficacy	Completed	Administer gel 12 h before and after sex; reduced women’s risk of HIV infection by sex by 39 % and also demonstrated decreased risk of acquiring HSV-2 (CAPRISA 004)
		Efficacy	Completed	Compare effectiveness of women’s daily oral TFV, daily oral TFV/FTC (emtricitabine), and daily TFV 1 % gel for HTV prevention. None of these formulations were shown to prevent HIV, however, participants did not adhere to administration regimen
		Efficacy	Ongoing	Test effectiveness of TFV 1 % gel in preventing HIV and HSV-2 infections in women. Used same dosing regimen as CAPRISA 2004
		PK/PD, safety	Completed	Evaluated TFV concentrations—low in blood, high in vaginal fluid
	PC-1005	Safety, efficacy, acceptability	Ongoing	Phase I trial to evaluate MTV-150 (NNRTI), co-formulated with zinc acetate carrageenan gel
	Dapivirine	Safety, PK, acceptability	Completed	Evaluate the safety, PK and acceptability of dapivirine gel against HTV-1
	MIV-150, zinc acetate, carrageenan (MZC)	Safety, PK	Ongoing	Phase 1 against HTV, HSV-2, and HPV
	GRFT (non-ARV)	Safety, PK, efficacy	Ongoing	Preclinical and clinical studies. Will inform future IVR and fiber designs
IVR	TFV	PK/PD and safety	Pending	Evaluate 90-day ring to assess safety, PK/PD, HIV-1 infectivity, and acceptability
	Dapivirine	Safety, PK, acceptability, long-term safety	Ongoing	Determine if ring is safe and effective to reduce risk of HIV infection
	Dapivirine + maravinoc combination	Safety, absorption	Completed	First clinical study vaginal microbicide with maraviroc and to combine two ARVs. Maraviroc-only did not protect, still looking at continuing optimizing combination. Dapavirine and combination ring prevented HIV challenge
	Polyurethane TDF	Safety and PK	Recruiting	Examine safety and PK of polyurethane TDF ring used for 14 days
	Maraviroc	Safety and efficacy	Recruiting	Two studies from MTN and IPM evaluating the safety and efficacy of monthly dapivirine vaginal ring
	MIV-150, zinc acetate, carrageenan (MZC)	Initial efficacy	Preclinical	Evaluate 90-day sustained-release IVR to prevent HSV-2, HIV, HPV, Trichomonas vaginalis
Film	TFV film (vs. gel)	Safety, efficacy ex vivo	Recruiting	Phase I trial to assess the safety of TFV gels and films
	Dapivirine film (vs. gel)	Safety, absorption, PK	Completed	Compared safety and PK of dapivirine film to dapivirine gel, both gel and film protected againt HIV in challenge model
Tablets	Vaginal TFV and TFV/FTC (Truvada)	PK/PD and safety	Ongoing	Evaluate fast-dissolve tablets to assess safety, PK/PD, acceptability, anti-HIV activity, and disintegration time
	Oral TFV/FTC (Truvada) vs. TFV reduced glycerin gel	Safety, acceptability, PK, absorption, adherence	Recruiting	Examine effects of oral Truvada and reduced glycerin l % TFV gel