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Early termination of a Phase 1 trial of tenofovir disoproxil fumarate intravaginal ring linked to inflammation

ABSTRACT: Objective: To assess safety in women of tenofovir disoproxil fumarate (TDF) polyurethane intravaginal ring (IVR) when used continuously for 3 months by healthy, HIV-uninfected, sexually active women, as compared with a placebo intravaginal ring

ORGANISM(S): Homo sapiens

PROVIDER: GSE122702 | GEO | 2020/04/13

REPOSITORIES: GEO

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Effect of pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine on gene expression in PBMC

Project description:Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) effectively prevents infection with HIV-1. We sought to determine how use of these medications affects gene expression. We performed a small, prospective trial (https://clinicaltrials.gov/ct2/show/NCT02621242) of eight men initiating PrEP with TDF/FTC. We obtained blood before treatment initiation and after two months of daily use. We isolated RNA from cryopreserved peripheral blood mononuclear cells (PBMC). Gene expression was measured from all eight men at both time points.

2020-07-07 | GSE139609 | GEO

Effect of pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine on gene expression in the blood

Project description:Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) effectively prevents infection with HIV-1. We sought to determine how use of these medications affects gene expression. We performed a small, prospective trial (https://clinicaltrials.gov/ct2/show/NCT02621242) of eight men initiating PrEP with TDF/FTC. We obtained blood before treatment initiation and after two months of daily use. We isolated RNA from whole blood (PAXgene tubes). Gene expression was measured from all eight men at both time points.

2020-07-07 | GSE139607 | GEO

Effect of pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine on gene expression in the rectum

Project description:Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) effectively prevents infection with HIV-1. We sought to determine how use of these medications affects gene expression. We performed a small, prospective trial (https://clinicaltrials.gov/ct2/show/NCT02621242) of eight men initiating PrEP with TDF/FTC. We obtained rectal biopsies before treatment initiation and after two months of daily use. We isolated RNA from rectal biopsies preserved with RNAlater. Gene expression was measured from all eight men at both time points.

2020-07-07 | GSE139610 | GEO

Effect of pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine on gene expression in the duodenum

Project description:Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) effectively prevents infection with HIV-1. We sought to determine how use of these medications affects gene expression. We performed a small, prospective trial (https://clinicaltrials.gov/ct2/show/NCT02621242) of eight men initiating PrEP with TDF/FTC. We obtained duodenal biopsies before treatment initiation and after two months of daily use. We isolated RNA from duodenal biopsies preserved with RNAlater. Gene expression was measured from all eight men at both time points.

2020-07-07 | GSE139608 | GEO

Early termination of a Phase 1 trial of tenofovir disoproxil fumarate intravaginal ring linked to inflammation

Project description:Early termination of a Phase 1 trial of tenofovir disoproxil fumarate intravaginal ring linked to inflammation

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A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

Project description:Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). The clinical results were reported here https://www.ncbi.nlm.nih.gov/pubmed/27986684. For the gene expression study, rectal biopsies were obtained from a subset of participants (n = 36) in the United States (Pittsburgh) and Thailand (Bangkok). Biopsies were provided at baseline and after each study period.

2020-07-07 | GSE138723 | GEO

Nucleos(t)ide analogs for hepatitis B virus infection differentially regulate the growth factor signaling in hepatocytes

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2024-01-17 | GSE249861 | GEO

Effect of pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine on gene expression

Project description:Effect of pre-exposure prophylaxis with tenofovir disoproxil fumarate and emtricitabine on gene expression

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Effect of antiretroviral prophylaxis on gene expression in the vagina

Project description:It is important to understand how, if at all, antiretroviral prophylaxis with tenofovir disoproxil fumarate (TDF) alone or TDF in conjunction with emtricitabine (FTC) affects gene expression. To ask this question, we used vaginal biopsies from women enrolled in the Genital Mucosal Substudy (GMS) [1] of the Partners PrEP Study (NCT02621242) [2]. Partners PrEP was a randomized Phase III trial of oral TDF or TDF/FTC compared to placebo, which showed that either active drug was effective at protecting against HIV-1 infection. Samples were taken after 24-36 months of oral treatment with placebo, TDF, or TDF/FTC or two months after discontinuation. Treatment adherence was based on plasma TDF concentrations. Covariates included Nugent scores (for bacterial vaginosis), HSV-2 serology, age, and birth control method. Levels of natural and synthetic hormones (medroxyprogesterone acetate [MPA], estradiol [E2], ethinyl estradiol [EE2], levonorgestrel [LNG], etonogestrel [ENG], progesterone [P4], and norethisterone enanthate [NET-EN]) were measured in the serum. 1. Lund, J. M. et al. HIV-1-Neutralizing IgA Detected in Genital Secretions of Highly HIV-1-Exposed Seronegative Women on Oral Preexposure Prophylaxis. J. Virol. 90, 9855–9861 (2016). 2. Baeten, J. M. et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N. Engl. J. Med. 367, 399–410 (2012).

2020-07-07 | GSE139654 | GEO

Effect of antiretroviral prophylaxis on gene expression in PBMCs

Project description:It is important to understand how, if at all, antiretroviral prophylaxis with tenofovir disoproxil fumarate (TDF) alone or TDF in conjunction with emtricitabine (FTC) affects gene expression. To ask this question, we used peripheral blood mononuclear cells from women enrolled in the Genital Mucosal Substudy (GMS) [1] of the Partners PrEP Study (NCT02621242) [2]. Partners PrEP was a randomized Phase III trial of oral TDF or TDF/FTC compared to placebo, which showed that either active drug was effective at protecting against HIV-1 infection. Samples were taken after 24-36 months of oral treatment with placebo, TDF, or TDF/FTC or two months after discontinuation. Treatment adherence was based on plasma TDF concentrations. Covariates included Nugent scores (for bacterial vaginosis), HSV-2 serology, age, and birth control method. Levels of natural and synthetic hormones (medroxyprogesterone acetate [MPA], estradiol [E2], ethinyl estradiol [EE2], levonorgestrel [LNG], etonogestrel [ENG], progesterone [P4], and norethisterone enanthate [NET-EN]) were measured in the serum. 1. Lund, J. M. et al. HIV-1-Neutralizing IgA Detected in Genital Secretions of Highly HIV-1-Exposed Seronegative Women on Oral Preexposure Prophylaxis. J. Virol. 90, 9855–9861 (2016). 2. Baeten, J. M. et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N. Engl. J. Med. 367, 399–410 (2012).

2020-07-07 | GSE139649 | GEO

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