Formulation development of dual-compartment topical inserts combining tenofovir alafenamide and elvitegravir for flexible on-demand HIV prevention. Agrahari V, Peet MM, Chandra N, Ramalingam P, Gupta PK, Jonnalagadda S, Singh ON, McCormick TJ, Doncel GF, Clark MR.J Control Release. 2024 Dec 6.
A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention. Riddler SA, Kelly CW, Hoesley CJ, Ho KS, Piper JM, Edick S, Heard F, Doncel GF, Johnson S, Anderson PL, Brand RM, Kunjara Na Ayudhya RP, Bauermeister JA, Hillier SL, Hendrix CW. 2024 Sep 23.
Preclinical and Early Clinical Development of Tenofovir Alafenamide/Elvitegravir Topical Inserts for Effective On-Demand Vaginal and Rectal HIV Prevention. Peet MM, Agrahari V, Clark MR, Doncel GF. 2024 Mar 1.
A conjoint experiment of three placebo rectal products used with receptive anal sex: results from MTN-035. Bauermeister J, Lin W, Tingler R, Liu A, Chariyalertsak S, Hoesley C, Gonzales P, Ho K, Kayange N, Phillips TP, Johnson S, Brown E, Zemanek J, Jacobson CE, Doncel GF, Piper J; MTN-035 Protocol Team for the Microbicide Trials Network. 2024 Mar.
Phase 1 randomized pharmacokinetic and safety study of a 90-day tenofovir vaginal ring in the United States. Liu AY, Gundacker H, Richardson B, Chen BA, Hoesley C, van der Straten A, Brown A, Beamer M, Robinson J, Jacobson CE, Scheckter R, Bunge K, Schwartz J, Thurman A, Piper JM, Marzinke MA; MTN-038 Protocol Team for the Microbicide Trials Network. 2024 Mar.
Preferences for Long-Acting PrEP Products Among Women and Girls: A Quantitative Survey and Discrete Choice Experiment in Eswatini, Kenya, and South Africa. Little KM, Hanif H, Anderson SM, Clark MR, Gustafson K, Doncel GF. 2024 Mar.
Extended post-exposure protection against vaginal SHIV infection with tenofovir alafenamide fumarate/elvitegravir inserts in macaques. Makarova N, Singletary T, Peet MM, Mitchell J, Bachman S, Holder A, Dinh C, Lipscomb J, Agrahari V, Mendoza M, Pan Y, Heneine W, Clark MR, García-Lerma JG, Doncel GF, Smith JM. 2023 Dec 22.
Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya. Mugo NR, Mudhune V, Heffron R, Thomas KK, McLellan-Lemal E, Njoroge B, Peacock S, O'Connor SM, Nyagol B, Ouma E, Ridzon R, Wiener J, Isoherranen N, Erikson DW, Ouattara LA, Yousefieh N, Jacot TA, Haaland RE, Morrison SA, Haugen HS, Thurman AR, Allen SA, Baeten JM, Samandari T, Doncel GF. 2023 Jun 13.
A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir. Thurman AR, Ouattara LA, Yousefieh N, Anderson PL, Bushman LR, Fang X, Hanif H, Clark M, Singh O, Doncel GF. 2023 Apr 19.
Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial. Tolley EE, Hanif H, Thurman A, Brache V, Doncel GF. 2023 Mar 30.
Randomized, placebo controlled phase I trial of the safety, pharmacokinetics, pharmacodynamics and acceptability of a 90 day tenofovir plus levonorgestrel vaginal ring used continuously or cyclically in women: The CONRAD 138 study. Thurman AR, Brache V, Cochon L, Ouattara LA, Chandra N, Jacot T, Yousefieh N, Clark MR, Peet M, Hanif H, Schwartz JL, Ju S, Marzinke MA, Erikson DW, Parikh U, Herold BC, Fichorova RN, Tolley E, Doncel GF. 2022 Oct 10.
End-user research in support of long-acting systemic antiretroviral delivery systems: insights from qualitative research with providers and target users in South Africa. Brown MS, Hanif H, Little KM, Clark MR, Thurman AR, Flomen L, Doncel GF. 2022 Dec 8.
Single dose topical inserts containing tenofovir alafenamide fumarate and elvitegravir provide pre- and post-exposure protection against vaginal SHIV infection in macaques. Dobard CW, Peet MM, Nishiura K, Holder A, Dinh C, Mitchell J, Khalil G, Pan Y, Singh ON, McCormick TJ, Agrahari V, Gupta P, Jonnalagadda S, Heneine W, Clark MR, García-Lerma JG, Doncel GF. 2022 Nov 21.
Pharmacokinetics and efficacy of topical inserts containing tenofovir alafenamide fumarate and elvitegravir administered rectally in macaques. Makarova N, Singletary T, Peet MM, Mitchell J, Holder A, Dinh C, Agrahari V, Mendoza M, Pan Y, Heneine W, Clark MR, García-Lerma JG, Smith JM, Doncel GF. 2022 Nov 5.
Long-acting HIV pre-exposure prophylaxis (PrEP) approaches: recent advances, emerging technologies, and development challenges. Agrahari V, Anderson SM, Peet MM, Wong AP, Singh ON, Doncel GF, Clark MR. 2022 Oct 25.
Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu Combined Ring Study, 2019. McLellan-Lemal E, Deaton SR, Betts JE, Ondenge K, Mudhune V, O'Connor SM, Nyagol B, Thurman AR, Doncel GF, Allen SA, Heffron R, Mugo NR; Kisumu Combined Ring Study (KCRS) Team. 2022 Sep 23.
Synthesis and Evaluation of Anti-HIV Activity of Mono- and Di-Substituted Phosphonamidate Conjugates of Tenofovir. Qureshi A, Ouattara LA, El-Sayed NS, Verma A, Doncel GF, Choudhary MI, Siddiqui H, Parang K. 2022 Jul 12.
Synthesis and Biological Evaluation of 5'-O-Fatty Acyl Ester Derivatives of 3'-Fluoro-2',3'-dideoxythymidine as Potential Anti-HIV Microbicides. Agarwal HK, Chhikara BS, Ye G, Bhavaraju S, Dixit A, Kumar A, Doncel GF, Parang K. 2022 May 23.
Genital microbiota of women using a 90 day tenofovir or tenofovir and levonorgestrel intravaginal ring in a placebo controlled randomized safety trial in Kenya. Dabee S, Mugo N, Mudhune V, McLellan-Lemal E, Peacock S, O'Connor S, Njoroge B, Nyagol B, Thurman AR, Ouma E, Ridzon R, Wiener J, Haugen HS, Gasper M, Feng C, Allen SA, Doncel GF, Jaspan HB, Heffron R; Kisumu Combined Ring Study Team. 2022 Jul 14.