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  • ||||||||||  tenofovir alafenamide/elvitegravir vaginal insert (TAF/EVG vaginal insert) / CONRAD
    Enrollment open:  Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert (clinicaltrials.gov) -  Dec 13, 2023   
    P1,  N=60, Recruiting, 
    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. Not yet recruiting --> Recruiting
  • ||||||||||  tenofovir alafenamide/elvitegravir vaginal insert (TAF/EVG vaginal insert) / CONRAD
    New P1 trial:  Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert (clinicaltrials.gov) -  Oct 17, 2023   
    P1,  N=60, Not yet recruiting, 
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    P2a data, PK/PD data, Journal:  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. (Pubmed Central) -  Jun 29, 2023   
    P2a
    We further evaluated TFV pharmacodynamics (PD) through ex vivo CVF activity against both human immunodeficiency virus (HIV)-1 and herpes simplex virus (HSV)-2, and LNG PD using cervical mucus quality markers and serum progesterone for ovulation inhibition...Steady state geometric mean amount (ssGMA) of vaginal TFV was comparable in the TFV/LNG and TFV IVR groups, 43,988 ng/swab (95% CI, 31,232, 61,954) and 30337?ng/swab (95% CI, 18,152, 50,702), respectively...Pharmacokinetics and markers of protection against HIV-1, HSV-2, and unintended pregnancy suggest the potential for clinical efficacy of the multipurpose TFV/LNG IVR. NCT03762382 [https://clinicaltrials.gov/ct2/show/NCT03762382].
  • ||||||||||  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.
  • ||||||||||  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 intravaginal ring (GS 1278) / Gilead, CONRAD
    PHASE I PK, SAFETY, AND ACCEPTABILITY STUDY OF A 90-DAY TENOFOVIR VAGINAL RING ([VIRTUAL]) -  Feb 7, 2022 - Abstract #CROI2022CROI_327;    
    The 90-day TFV ring was well-tolerated, acceptable, and exceeded target cervical tissue concentrations through day 56, but declined thereafter. Additional studies should characterize the higher release from TFV rings in some participants and the optimal duration of use.
  • ||||||||||  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.
  • ||||||||||  elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases
    Trial completion:  Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) -  Oct 18, 2021   
    P1,  N=23, Completed, 
    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. Recruiting --> Completed
  • ||||||||||  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.
  • ||||||||||  elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases
    [VIRTUAL] PHARMACOKINETICS OF TAF/EVG RECTAL INSERTS IN MACAQUES AND IMPACT OF RECTAL WASH () -  Mar 18, 2021 - Abstract #CROI2021CROI_913;    
    Rectal wash was associated with extended biodistribution of TFV-DP and EVG throughout the rectum and increased tissue drug levels by several orders of magnitude. SHIV challenge studies will help define the rectal protection achieved with TAF/EVG inserts.
  • ||||||||||  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.
  • ||||||||||  elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases
    Trial completion date, Trial primary completion date:  Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) -  Aug 19, 2020   
    P1,  N=20, Recruiting, 
    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. Trial completion date: Aug 2020 --> Mar 2021 | Trial primary completion date: Aug 2020 --> Mar 2021
  • ||||||||||  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:  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.
  • ||||||||||  elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases
    Enrollment open:  Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) -  Jun 9, 2020   
    P1,  N=20, Recruiting, 
    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. Active, not recruiting --> Recruiting
  • ||||||||||  elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases
    Enrollment closed:  Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) -  Apr 7, 2020   
    P1,  N=20, Active, not recruiting, 
    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. Recruiting --> Active, not recruiting
  • ||||||||||  TAF/EVG vaginal insert / CONRAD, elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    [VIRTUAL] ON-DEMAND HIV POSTEXPOSURE PROPHYLAXIS BY TAF/EVG VAGINAL INSERTS IN MACAQUES ([VIRTUAL]) -  Mar 2, 2020 - Abstract #CROI2020CROI_244;    
    The observed high levels of TFV-DP in PBMCs by topical delivery of TAF is unique and may have contributed to protection. Our data support the clinical development of TAF/EVG inserts for on-demand PrEP/PEP for HIV prevention.
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    Trial completion date, Adherence:  Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring (clinicaltrials.gov) -  Jan 14, 2020   
    P2a,  N=50, Active, not recruiting, 
    Our data support the clinical development of TAF/EVG inserts for on-demand PrEP/PEP for HIV prevention. Trial completion date: Aug 2019 --> Apr 2020
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    Trial completion, Trial completion date, Trial primary completion date:  Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir (clinicaltrials.gov) -  Oct 6, 2019   
    P1,  N=49, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Feb 2020 --> Sep 2019 | Trial primary completion date: Feb 2020 --> Sep 2019
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    Enrollment closed, Adherence:  Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring (clinicaltrials.gov) -  Aug 8, 2019   
    P2a,  N=50, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Feb 2020 --> Sep 2019 | Trial primary completion date: Feb 2020 --> Sep 2019 Enrolling by invitation --> Active, not recruiting
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    Trial primary completion date, Adherence:  Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring (clinicaltrials.gov) -  Jul 26, 2019   
    P2a,  N=50, Enrolling by invitation, 
    Enrolling by invitation --> Active, not recruiting Trial primary completion date: May 2019 --> Aug 2019
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    Enrollment closed:  Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir (clinicaltrials.gov) -  Jul 24, 2019   
    P1,  N=48, Active, not recruiting, 
    Trial primary completion date: May 2019 --> Aug 2019 Recruiting --> Active, not recruiting
  • ||||||||||  tenofovir alafenamide/elvitegravir vaginal insert (TAF/EVG vaginal insert) / CONRAD
    Trial completion:  Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG (clinicaltrials.gov) -  Jul 15, 2019   
    P1,  N=16, Completed, 
    Recruiting --> Active, not recruiting Recruiting --> Completed
  • ||||||||||  tenofovir alafenamide/elvitegravir vaginal insert (TAF/EVG vaginal insert) / CONRAD
    Enrollment open:  Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG (clinicaltrials.gov) -  Jan 30, 2019   
    P1,  N=16, Recruiting, 
    Not yet recruiting --> Enrolling by invitation Not yet recruiting --> Recruiting
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    Trial completion date, Trial primary completion date:  Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir (clinicaltrials.gov) -  Dec 20, 2018   
    P1,  N=48, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Nov 2019 --> Feb 2020 | Trial primary completion date: Feb 2019 --> Feb 2020
  • ||||||||||  tenofovir intravaginal ring (GS 1278) / Gilead, CONRAD
    Enrollment open:  Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir (clinicaltrials.gov) -  Dec 17, 2018   
    P1,  N=48, Recruiting, 
    Trial completion date: Nov 2019 --> Feb 2020 | Trial primary completion date: Feb 2019 --> Feb 2020 Not yet recruiting --> Recruiting