HIV Prevention Technologies

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.
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.
Acceptability of a Long-Acting, Multipurpose Vaginal Ring: Findings from a Phase I Trial in the U.S. and Dominican Republic. Tolley EE, Zissette S, Taylor J, Hanif H, Ju S, Schwarz J, Thurman A, Tyner D, Brache V, Doncel GF. 2022 Apr 1.
Vaginal Microbiota and Mucosal Pharmacokinetics of Tenofovir in Healthy Women Using a 90-Day Tenofovir/Levonorgestrel Vaginal Ring. Thurman AR, Ravel J, Gajer P, Marzinke MA, Ouattara LA, Jacot T, Peet MM, Clark MR, Doncel GF. 2022 Mar 8. 
Safety and Pharmacokinetics of a Tenofovir Alafenamide Fumarate-Emtricitabine based Oral Antiretroviral Regimen for Prevention of HIV Acquisition in Women: A Randomized Controlled Trial. Thurman AR, Schwartz JL, Cottrell ML, Brache V, Chen BA, Cochón L, Ju S, McGowan I, Rooney JF, McCallister S, Doncel GF. 2021 May 23.
Topical Inserts: A Versatile Delivery Form for HIV Prevention. Peet MM, Agrahari V, Anderson SM, Hanif H, Singh ON, Thurman AR, Doncel GF, Clark MR. 2019 Aug 1.
Differences in Local and Systemic TFV PK Among Premenopausal Versus Postmenopausal Women Exposed to TFV 1% Vaginal Gel. Thurman AR, Chandra N, Yousefieh N, Kimble T, Anderson SM, Cottrell M, Sykes C, Kashuba A, Schwartz JL, Doncel GF. 2018 May 1.

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