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- || Dapivirine Vaginal Ring (dapivirine) / International Partnership for Microbicides, J&J, tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Retrospective data, Review, Journal: Perinatal outcomes associated with pre-exposure prophylaxis for HIV prevention during pregnancy: a systematic review and meta-analysis. (Pubmed Central) - Apr 30, 2024
There was no association of the dapivirine vaginal ring with PTB or NND, compared to placebo or oral TDF/FTC PrEP...More data is needed to assess the safety of all PrEP modalities in pregnancy. None.
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Journal: Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application. (Pubmed Central) - Mar 7, 2024
None. The current study provides first of its kind physiologically based pharmacokinetic framework integrating physiology, population and formulation data to carry out in silico mechanistic vaginal absorption studies, with the potential for virtual bioequivalence assessment in the future.
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Journal: Genital immune cell activation and tenofovir gel efficacy: a case-control study. (Pubmed Central) - Oct 4, 2022
Genital inflammation (GI) undermines topical HIV pre-exposure prophylaxis (PrEP) efficacy through unknown mechanisms. Here, associations between activated endocervical CD4+ T cell numbers and higher deoxyadenosine triphosphate (dATP) concentrations suggest that competition for intracellular metabolites within HIV target cells may reduce the efficacy of antiretroviral-based PrEP in women with GI.
- || emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Clinical, PK/PD data, Journal: An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine / Tenofovir Disoproxil Fumarate. (Pubmed Central) - Apr 12, 2022
P2
Despite significant differences in systemic and mucosal drug concentrations, all three PrEP regimens were able to protect rectal explants from ex vivo HIV infection. These data suggest that there is a rationale for co-development of oral and topical antiretroviral PrEP for HIV prevention.
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Biomarker, Journal: Pre-infection plasma cytokines and chemokines as predictors of HIV disease progression. (Pubmed Central) - Mar 12, 2022
Here we examined the relationship between pre-infection plasma cytokine expression and the rate of HIV disease progression in South African women who seroconverted during the CAPRISA 004 tenofovir gel trial...The strongest association with peak viral load was observed for SCGFβ, which was also inversely associated with lowest CD4:CD8 ratio < 180 days post infection and faster CD4 decline below 500 cells/µl (adjusted HR 4.537, 95% CI 1.475-13.954; p = 0.008) in multivariable analysis adjusting for age, study site, contraception, baseline HSV-2 status and trial arm allocation. Our results show that pre-infection systemic immune responses could play a role in HIV disease progression, especially in the early stages of infection.
- || tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Clinical, Journal: Higher mucosal antibody concentrations in women with genital tract inflammation. (Pubmed Central) - Jan 27, 2022
Immunoglobulin (Ig) isotypes, IgG subclasses and 48 cytokines were measured prior to HIV infection in cervicovaginal lavages (CVL) from 66 HIV seroconverters (cases) and 66 matched HIV-uninfected women (controls) enrolled in the CAPRISA 004 and 008 1% tenofovir gel trials...The strong and significant positive correlations between mucosal antibodies and markers of GI suggest that GI may impact mucosal antibody profiles. These findings require further investigation to establish a plausible biological link between the local inflammatory milieu and its consequence on these genital antibodies.
- || tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Clinical, Journal: HIV Incidence Among Pregnant and Nonpregnant Women in the FACTS-001 Trial: Implications for HIV Prevention, Especially PrEP Use. (Pubmed Central) - Jan 18, 2022
Risks from reductions in condom use may be offset by reduced sexual activity. Nevertheless, high HIV incidence in both pregnant and nonpregnant women supports consideration of introducing antiretroviral-containing pre-exposure prophylaxis for pregnant and nonpregnant women in high HIV prevalence settings.
- || tenofovir disoproxil fumarate / Generic mfg.
Clinical, Journal: Topical Tenofovir Pre-exposure Prophylaxis and Mucosal HIV-Specific Fc-Mediated Antibody Activities in Women. (Pubmed Central) - Apr 13, 2021
Our previous findings of increased HIV specific antibody detection and titres in women who used tenofovir gel, and the limited differences in nNAb activities between the arms, suggest that prior PrEP did not modulate these nNAb functions post-HIV seroconversion. Together these data provide insight into envelope-specific-nNAb Fc-mediated functions at the site of exposure which may inform on ensuing immunity during combination HIV prevention strategies including PrEP and HIV vaccines.
- tenofovir vaginal gel (GS-1278 gel) / CONRAD, Gilead
[VIRTUAL] Modeling the probability of HIV infection and its reduction by microbicides using deterministic mass transport theory coupled to viral dynamics () - Feb 7, 2021 - Abstract #HIVR4P2021HIVR4P_422;
Inputting product properties, it provides a mechanistic means of evaluating, screening and optimizing those properties, complementing in vitro and in vivo experiments. Further, it can simulate diverse patient populations.
- tenofovir vaginal gel (GS-1278 gel) / CONRAD, Gilead
[VIRTUAL] Comparing Applicator vs. “As Lubricant” Delivery of Rectal Dapivirine Gel (MTN-033) (Live channel 2) - Feb 7, 2021 - Abstract #HIVR4P2021HIVR4P_77;
Tenofovir gel administered intrarectally with an applicator had lower acceptability as compared to a daily oral PrEP regimen and traditional lubricant use in prior phase II studies...Our data suggests that DPV gel was safe and easy to use. Further development of a lubricant microbicide strategy is warranted.
- | tenofovir vaginal gel (GS-1278 gel) / CONRAD, Gilead
Journal: Treatment with Commonly Used Antiretroviral Drugs Induces a Type I/III Interferon Signature in the Gut in the Absence of HIV Infection. (Pubmed Central) - Oct 7, 2020
mRNA sequencing, digital droplet PCR, proteomics, and immunofluorescence confirm IFN I/III pathway stimulation in the gastrointestinal tract. Thus, oral TDF/FTC stimulates an IFN I/III signature throughout the gut, which could increase antiviral efficacy but also cause chronic immune activation in HIV prevention and treatment settings.
- || tenofovir vaginal gel (GS-1278 gel) / CONRAD, Gilead
Clinical, Journal: Frequency of Hepatitis B Virus Resistance Mutations in Women Using Tenofovir Gel as Pre-Exposure Prophylaxis. (Pubmed Central) - Jul 29, 2020
All samples belonged to HBV genotype A. None of the known tenofovir resistance mutations (M240V/I, L180M, A194T, V214A, N238T) were identified in any individuals. While it is reassuring that no resistance mutations were found among women using topical tenofovir, the rapidly expanding access to oral tenofovir-containing HIV pre-exposure prophylaxis (PrEP), with higher systemic exposure to the drug, makes monitoring for potential HBV drug resistance important.
- || Clinical, Journal, Head-to-Head: Integrated provision of topical pre-exposure prophylaxis in routine family planning services in South Africa: a non-inferiority randomized controlled trial. (Pubmed Central) - Jul 16, 2020
Provision of topical PrEP as part of an integrated FP service achieved higher adherence, and was as feasible, acceptable and effective in preventing HIV as provision through a research setting. This provides useful evidence for scale-up of oral PrEP in urban and rural high burden communities.
- || Clinical, Journal: Impact of Case Definitions on Efficacy Estimation in Clinical Trials-A Proof-of-Principle Based on Historical Examples. (Pubmed Central) - Jul 9, 2020
After describing the structure of case definitions and its impact on efficacy estimations, we exemplify this impact using data from two clinical trials dealing with the effectiveness of the vaginal application of tenofovir gel for the prevention of HIV infections and with the therapeutic effects of fecal transplantation on recurrent Clostridiumdifficile infections...The potential risk of bias and uncertainty is high, irrespective of the complexity of the case definition. Accordingly, case definitions in clinical trials should focus on specificity in order to avoid the risk of bias.
- [VIRTUAL] High Y-chromosome DNA concentrations are associated with increased cervical cytokine concentrations and activated cervical HIV target cell frequencies (Abstract Sessions On-Demand Channel) - Jun 22, 2020 - Abstract #AIDS2020AIDS_1776;
Higher YcDNA concentrations were associated with raised levels of cytokines and MMPs, and with greater frequencies of HIV target cells at the female genital mucosa. Considering the association between YcDNA and these established biomarkers of genital inflammation and HIV risk, semen-induced alterations at the FGT may, therefore, have implications for HIV susceptibility in women.
- || Clinical, Review, Journal: The genital tract and rectal microbiomes: their role in HIV susceptibility and prevention in women. (Pubmed Central) - Apr 10, 2020
Considering the association between YcDNA and these established biomarkers of genital inflammation and HIV risk, semen-induced alterations at the FGT may, therefore, have implications for HIV susceptibility in women. A better understanding of the composition, structure and function of the microbiome is needed to identify opportunities to alter the vaginal microbiome and prevent BV and reduce the risk of HIV acquisition.
- ||||||| tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion, Enrollment change: Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services (clinicaltrials.gov) - Jan 28, 2016
P2/3, N=382, Completed, Sponsor: Centre for the AIDS Programme of Research in South Africa
A better understanding of the composition, structure and function of the microbiome is needed to identify opportunities to alter the vaginal microbiome and prevent BV and reduce the risk of HIV acquisition. Active, not recruiting --> Completed | N=700 --> 382
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion: FAME-05: Comparison of Tenofovir Vaginal Gel and Film Formulations (clinicaltrials.gov) - Jan 28, 2016
P0, N=10, Completed, Sponsor: CONRAD
Active, not recruiting --> Completed | N=700 --> 382 Recruiting --> Completed
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion, P1 data, Trial primary completion date: A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 (clinicaltrials.gov) - Sep 8, 2015
P1, N=78, Completed, Sponsor: CONRAD
Recruiting --> Completed Recruiting --> Completed | Trial primary completion date: May 2015 --> Jan 2015
- ||||| tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment closed: Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services (clinicaltrials.gov) - Sep 3, 2015
P2/3, N=700, Active, not recruiting, Sponsor: Centre for the AIDS Programme of Research in South Africa
Recruiting --> Completed | Trial primary completion date: May 2015 --> Jan 2015 Recruiting --> Active, not recruiting
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment open, Trial primary completion date: FAME-05: Comparison of Tenofovir Vaginal Gel and Film Formulations (clinicaltrials.gov) - Jun 6, 2015
P0, N=10, Recruiting, Sponsor: CONRAD
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Trial primary completion date: May 2015 --> Dec 2015
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion, Preclinical, Enrollment change: In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products (clinicaltrials.gov) - May 22, 2015
P1, N=101, Completed, Sponsor: CONRAD
Not yet recruiting --> Recruiting | Trial primary completion date: May 2015 --> Dec 2015 Active, not recruiting --> Completed | N=54 --> 101
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment change, Trial withdrawal, Trial primary completion date: Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females (clinicaltrials.gov) - May 1, 2015
P1, N=0, Withdrawn, Sponsor: CONRAD
Active, not recruiting --> Completed | N=54 --> 101 N=60 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2015 --> Apr 2015
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion, Enrollment change, Trial primary completion date: Coital Pharmacokinetics/Pharmacodynamics (PK/PD) of Tenofovir Gel (clinicaltrials.gov) - Apr 16, 2015
P1, N=31, Completed, Sponsor: CONRAD
N=60 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2015 --> Apr 2015 Recruiting --> Completed | N=80 --> 31 | Trial primary completion date: Sep 2014 --> Jun 2014
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion, Enrollment change: Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection (clinicaltrials.gov) - Apr 16, 2015
P3, N=2059, Completed, Sponsor: CONRAD
Recruiting --> Completed | N=80 --> 31 | Trial primary completion date: Sep 2014 --> Jun 2014 Active, not recruiting --> Completed | N=2900 --> 2059
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment change, Trial withdrawal: Paper Applicator Acceptability Study (clinicaltrials.gov) - Apr 15, 2015
P1/2, N=0, Withdrawn, Sponsor: CONRAD
Active, not recruiting --> Completed | N=2900 --> 2059 N=100 --> 0 | Not yet recruiting --> Withdrawn
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial primary completion date: Paper Applicator Acceptability Study (clinicaltrials.gov) - Apr 15, 2015
P1/2, N=0, Withdrawn, Sponsor: CONRAD
N=100 --> 0 | Not yet recruiting --> Withdrawn Trial primary completion date: Dec 2015 --> Mar 2015
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment change, Trial withdrawal: Evaluating the Safety of Tenofovir Vaginal Gel in HIV-Uninfected Pregnant Women (clinicaltrials.gov) - Apr 14, 2015
P2, N=0, Withdrawn, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial primary completion date: Dec 2015 --> Mar 2015 N=384 --> 0 | Not yet recruiting --> Withdrawn
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion: Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity (clinicaltrials.gov) - Apr 10, 2015
P1, N=40, Completed, Sponsor: CONRAD
N=384 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Completed
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion: Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use (clinicaltrials.gov) - Apr 10, 2015
P1, N=72, Completed, Sponsor: CONRAD
Recruiting --> Completed Active, not recruiting --> Completed
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion, Enrollment change, Trial primary completion date: Trial to Assess the Impact of PrEP to Tenofovir Gel on the Efficacy of Tenofovir-containing ART on Viral Suppression (clinicaltrials.gov) - Feb 5, 2015
P=N/A, N=59, Completed, Sponsor: Centre for the AIDS Programme of Research in South Africa
Active, not recruiting --> Completed Enrolling by invitation --> Completed | N=90 --> 59 | Trial primary completion date: Jun 2014 --> Nov 2014
- Trial completion, Trial primary completion date: Project Gel: Microbicide Safety and Acceptability in Young Men (clinicaltrials.gov) - Dec 24, 2014
P1, N=249, Completed, Sponsor: CONRAD
Enrolling by invitation --> Completed | N=90 --> 59 | Trial primary completion date: Jun 2014 --> Nov 2014 Active, not recruiting --> Completed | Trial primary completion date: Sep 2014 --> May 2013
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment closed, Preclinical: In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products (clinicaltrials.gov) - Oct 28, 2014
P1, N=54, Active, not recruiting, Sponsor: CONRAD
Active, not recruiting --> Completed | Trial primary completion date: Sep 2014 --> May 2013 Recruiting --> Active, not recruiting
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
New P1 trial: Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females (clinicaltrials.gov) - Sep 22, 2014
P1, N=60, Not yet recruiting, Sponsor: CONRAD
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
New P1/2 trial: Paper Applicator Acceptability Study (clinicaltrials.gov) - Jul 1, 2014
P1/2, N=100, Not yet recruiting, Sponsor: CONRAD
- Trial primary completion date: Project Gel: Microbicide Safety and Acceptability in Young Men (clinicaltrials.gov) - Jun 27, 2014
P1, N=240, Active, not recruiting, Sponsor: CONRAD
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2013 --> Sep 2014
- Enrollment closed, Trial primary completion date: Project Gel: Microbicide Safety and Acceptability in Young Men (clinicaltrials.gov) - Jun 27, 2014
P1, N=240, Active, not recruiting, Sponsor: CONRAD
Trial primary completion date: Dec 2013 --> Sep 2014 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2013 --> Sep 2014
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial primary completion date: Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection (clinicaltrials.gov) - Jun 18, 2014
P3, N=2900, Active, not recruiting, Sponsor: CONRAD
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2013 --> Sep 2014 Trial primary completion date: May 2014 --> Aug 2014
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment closed, Trial primary completion date: Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection (clinicaltrials.gov) - Jun 18, 2014
P3, N=2900, Active, not recruiting, Sponsor: CONRAD
Trial primary completion date: May 2014 --> Aug 2014 Recruiting --> Active, not recruiting | Trial primary completion date: May 2014 --> Aug 2014
- || tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial primary completion date: Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding (clinicaltrials.gov) - Jun 2, 2014
P4, N=55, Active, not recruiting, Sponsor: University of Washington
Recruiting --> Active, not recruiting | Trial primary completion date: May 2014 --> Aug 2014 Trial primary completion date: Dec 2013 --> Jun 2015
- ||| tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment closed: Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding (clinicaltrials.gov) - Jun 2, 2014
P4, N=55, Active, not recruiting, Sponsor: University of Washington
Trial primary completion date: Dec 2013 --> Jun 2015 Recruiting --> Active, not recruiting
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion: An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations (clinicaltrials.gov) - May 5, 2014
P1, N=9, Completed, Sponsor: Ian McGowan
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial initiation date: An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations (clinicaltrials.gov) - May 5, 2014
P1, N=9, Active, not recruiting, Sponsor: Ian McGowan
Active, not recruiting --> Completed Initiation date: Apr 2012 --> Feb 2013
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion: Safety and Acceptability of a Vaginal Microbicide (clinicaltrials.gov) - Feb 22, 2014
P2, N=200, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Initiation date: Apr 2012 --> Feb 2013 Active, not recruiting --> Completed
- | tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD, tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
Trial completion: Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel (clinicaltrials.gov) - Feb 22, 2014
P1, N=120, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed No longer recruiting --> Completed
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment open, Preclinical: In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products (clinicaltrials.gov) - Dec 19, 2013
P1, N=54, Recruiting, Sponsor: CONRAD
No longer recruiting --> Completed Not yet recruiting --> Recruiting
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment open, P1 data: A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 (clinicaltrials.gov) - Dec 12, 2013
P1, N=80, Recruiting, Sponsor: CONRAD
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment change: Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel (clinicaltrials.gov) - Dec 10, 2013
P1, N=194, Completed, Sponsor: CONRAD
Not yet recruiting --> Recruiting N=100 --> 194
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Enrollment closed: Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use (clinicaltrials.gov) - Dec 10, 2013
P1, N=72, Active, not recruiting, Sponsor: CONRAD
N=100 --> 194 Recruiting --> Active, not recruiting
- tenofovir vaginal gel (GS-1278 gel) / Gilead, CONRAD
Trial completion: Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel (clinicaltrials.gov) - Dec 10, 2013
P1, N=194, Completed, Sponsor: CONRAD
Recruiting --> Active, not recruiting Active, not recruiting --> Completed