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26 Diseases |  |
58 Trials |
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58 Trials |  |
4692 News |  |
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- || Elpida (elsulfavirine) / Viriom
Trial completion: Study to Evaluate the Safety and PK of Elpida (clinicaltrials.gov) - Jan 11, 2022
P1, N=36, Completed, Sponsor: Viriom
Recruiting --> Completed
- ||||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical: Dolutegravir-based antiretroviral therapy was superior to other regimens in children and teens with HIV-1 infection who were starting first- or second-line ART. https://t.co/xw2yOpRB6K #HIV #dolutegravir @CarlosdelRio7 (Twitter) - Jan 10, 2022
- ||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Review: Preeminence of Dolutegravir-Based Antiretroviral Therapy in Children and Adolescents. My review and commentary in @JWatch on the recent paper in @NEJM confirming that DTG-based ART should be the preferred regimen in children and adolescents https://t.co/EuaJvhle7C (Twitter) - Jan 10, 2022
- | Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Trial primary completion date, Adherence: APTAMER: Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs (clinicaltrials.gov) - Jan 10, 2022
P1, N=30, Active, not recruiting, Sponsor: Rhonda Brand
Recruiting --> Completed Trial primary completion date: Dec 2021 --> Sep 2021
- || Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: DOLUVOIR: Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors Backbone (clinicaltrials.gov) - Jan 5, 2022
P=N/A, N=34, Recruiting, Sponsor: ANRS, Emerging Infectious Diseases
Trial primary completion date: Dec 2021 --> Sep 2021 Trial completion date: Feb 2021 --> Nov 2023 | Trial primary completion date: Feb 2021 --> Oct 2022
- | Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
Trial completion: OPTIPRIM-2: National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection (clinicaltrials.gov) - Jan 4, 2022
P3, N=101, Completed, Sponsor: ANRS, Emerging Infectious Diseases
Trial completion date: Feb 2021 --> Nov 2023 | Trial primary completion date: Feb 2021 --> Oct 2022 Active, not recruiting --> Completed
- || Clinical, Journal: Possible Herb-Drug Interaction Risk of Some Nutritional and Beauty Supplements on Antiretroviral Therapy in HIV Patients. (Pubmed Central) - Jan 1, 2022
Of the five drugs, rilpivirine and dolutegravir metabolism was increased by up to 2-folds over the no supplement control by some of the supplements. Our findings indicate that concomitant consumption of these products with anti-HIV drugs may compromise the efficacy of antivirals therapy due to supplement-induced metabolism via induction of CYP3A4 activity.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Box-Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of Dolutegravir sodium and Lamivudine co-loaded in nano-liposomes. (Pubmed Central) - Jan 1, 2022
The validated reverse phase HPLC method exhibited specificity for both dolutegravir sodium and lamivudine in the presence of degradation products as well as the liposomal matrix. This method was effectively utilized to determine the amount of drug entrapped and drug loading efficiency of dolutegravir sodium and lamivudine in a nano-liposomal formulation.
- || Biomarker, Clinical, Observational data, Journal: Evaluation of several serum interleukins as markers for treatment effectiveness in naïve HIV infected patients: A pilot study. (Pubmed Central) - Jan 1, 2022
Dolutegravir showed a tendency to statistically significant changes in IL-4 and IL-10. A clinical trial with random allocation of medication and an extensive follow-up is needed to replicate this research and validate the usefulness of evaluated ILs as markers of cART effectiveness.
- || Edurant (rilpivirine) / J&J
Clinical, Journal: Durability of rilpivirine- versus integrase inhibitor-based regimens in a large cohort of naïve HIV-infected patients starting antiretroviral therapy. (Pubmed Central) - Dec 30, 2021
A clinical trial with random allocation of medication and an extensive follow-up is needed to replicate this research and validate the usefulness of evaluated ILs as markers of cART effectiveness. In ART-naïve patients with low viral loads and high CD4 counts, the risk of treatment failure was lower in those who started RPV-based vs. INSTIs-based regimens other than DTG-based ones.
- | bictegravir (GS-9883) / Gilead
Journal: HIV Pretreatment Drug Resistance Trends in Mexico City, 2017-2020. (Pubmed Central) - Dec 29, 2021
PDR to dolutegravir/bictegravir remained low in Mexico City, although further surveillance is warranted given the short time of ART optimization. Our study identifies demographic characteristics of groups with higher risk of PDR and lost to follow-up, which may be useful to design differentiated interventions locally.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Body Fat Distribution and Metabolic Changes in a Cohort of Adolescents Living With HIV Switched to an Antiretroviral Regimen Containing Dolutegravir. (Pubmed Central) - Dec 28, 2021
Total and low density lipoprotein cholesterol decreased after 3 months. Increase in trunk fat may put at risk of future cardiovascular problems, despite improvement in the lipid profile.
- || Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
Clinical, Journal: Increase in Body Mass Index in Children With HIV, Switched to Tenofovir Alafenamide Fumarate or Dolutegravir Containing Antiretroviral Regimens. (Pubmed Central) - Dec 28, 2021
Increase in trunk fat may put at risk of future cardiovascular problems, despite improvement in the lipid profile. No abstract available
- | Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Journal: Preparation and Characterization of Stable Amorphous Glassy Solution of BCS II and IV Drugs. (Pubmed Central) - Dec 27, 2021
Furthermore, AGSs were stable against devitrification on exposure to high temperature and humidity. In summary, SAIB can be employed to develop stable AGSs of poorly soluble drugs to increase dissolution, and oral bioavailability with the addition of hydrophilic excipients.
- | Tivicay (dolutegravir) / ViiV Healthcare
New P1 trial: QL-YK1-045-001: Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects in the Fasting and Fed State (clinicaltrials.gov) - Dec 23, 2021
P1, N=64, Recruiting, Sponsor: The Affiliated Hospital of Qingdao University
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Resource and infrastructure challenges on the RESIST-2 Trial: an implementation study of drug resistance genotype-based algorithmic ART switches in HIV-2-infected adults in Senegal. (Pubmed Central) - Dec 21, 2021
P=N/A
In summary, SAIB can be employed to develop stable AGSs of poorly soluble drugs to increase dissolution, and oral bioavailability with the addition of hydrophilic excipients. The RESIST-2 trial demonstrated that a DBS-based genotypic test can be used to help inform second-line ART decisions as part of a programmatic algorithm in RLS, albeit with significant implementation challenges.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Provider perspectives on the acceptability and tolerability of dolutegravir-based anti-retroviral therapy after national roll-out in Uganda: a qualitative study. (Pubmed Central) - Dec 18, 2021
While DTG-based regimens were perceived by clinicians in ART clinics to be well tolerated by the majority of their patients, they also reported that a number of patients experience suspected ADRs key among which were hyperglycemia, insomnia and reduced libido. Based on the perspectives of clinicians, we recommend that future studies examine the prevalence of dolutegravir-induced hyperglycemia in patients in Uganda.
- || bictegravir (GS-9883) / Gilead
PK/PD data, Review, Journal: Pharmacokinetic drug interactions of integrase strand transfer inhibitors. (Pubmed Central) - Dec 16, 2021
While raltegravir undergoes biotransformation by the UDP-glucuronosyltransferases (UGTs), elvitegravir is primarily metabolized by cytochrome P450 (CYP) 3A4 and co-formulated with cobicistat to increase its plasma exposure...Also, common geriatric challenges such as multimorbidity and polypharmacy have been increasingly recognized in PWH. This review provides a summary of pharmacokinetic interactions with INSTIs and future perspectives in implications of INSTI drug interactions.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, PK/PD data, Journal: Pharmacokinetic parameters and weight change in HIV patients newly switched to dolutegravir-based regimens in SIMPL'HIV clinical trial. (Pubmed Central) - Dec 16, 2021
DTG plasma exposure was not significantly associated with weight gain, even after adjusting for potential confounders (p=0.9). We found no significant association between DTG pharmacokinetic parameters and weight gain amongst PWHIV newly switched to a DTG-based dual regimen.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Dual therapy with dolutegravir plus boosted protease inhibitor as a maintenance or salvage therapy in highly experienced people living with HIV. (Pubmed Central) - Dec 16, 2021
Compared with baseline, the mean total cholesterol increased by 20.1 mg/dl and weight by 2.8 kg at Week 48, while the estimated glomerular filtration rate decreased by 14.4 mL/min/1.73m (both p<0.05). We conclude that two-drug regimen containing dolutegravir plus bPI was effective in highly experienced HIV-positive patients, but metabolic impact and weight gain should be closely monitored.
- | Tivicay (dolutegravir) / ViiV Healthcare
Preclinical, Journal: Combined cART including Tenofovir Disoproxil, Emtricitabine, and Dolutegravir has potent therapeutic effects in HIV-1 infected humanized mice. (Pubmed Central) - Dec 16, 2021
That is easier to manage when working with humanized mouse models, although we realize the limitations due to low human cell recovery and thus the number of cells available for thorough and comprehensive analyses. Nonetheless, our data further confirm that the CD34+ humanized mouse model is a potentially useful pre-clinical model to study and improve current anti-HIV-1 therapies.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Expanding the use of dolutegravir-based antiretroviral therapy in multidrug-resistant TB. (Pubmed Central) - Dec 16, 2021
While the uptake of DTG-based ART in programs where drug-resistant TB is treated remains unknown, there is early evidence from three programs that uptake is increasing. The use of DTG-based ART should be scaled-up, beginning with antiretroviral-naïve or virologically suppressed patients initiating MDR-TB treatment.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Cohort profile: the Netherlands Cohort Study on Acute HIV infection (NOVA), a prospective cohort study of people with acute or early HIV infection who immediately initiate HIV treatment. (Pubmed Central) - Dec 16, 2021
The Netherlands Cohort Study on Acute HIV infection remains open for participant enrolment and for additional sites to join the network. This cohort provides a unique nationwide platform for conducting future in-depth virological, immunological, host genetic and interventional studies investigating HIV-cure strategies.
- || dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Mylan, Hetero, Macleods, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Time to Immunologic Recovery and Its Determinant Factors Among Adult HIV Patients Who Initiated Antiretroviral Treatment at Hiwot Fana Specialized University Hospital, Harar, Ethiopia. (Pubmed Central) - Dec 13, 2021
HIV patients with working functional status should be given the necessary attention. Utilization of dolutegravir-based regimens should be encouraged to attain a normal CD4 count earlier.
- Tivicay (dolutegravir) / ViiV Healthcare
SETTING THE STAGE: POSTNATAL PROPHYLAXIS TO REDUCE NEW PEDIATRIC INFECTIONS ([VIRTUAL]) - Dec 9, 2021 - Abstract #CROI2022CROI_71;
Whilst late initiation of ART remains a key driver of intrauterine and intrapartum transmissions, the WHO preferred first-line regimen of Dolutegravir plus an NRTI-backbone results in rapid viral load suppression in women starting ART in pregnancy...This talk will review the current status of vertical transmission prevention including the roll-out of antenatal ART and the timing of transmission, before examining current PNP guidelines in different settings and related implementation challenges. The place that PNP has in prevention of vertical transmission strategies if all pregnant and breastfeeding women are on ART will be discussed.
- Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
Evaluating Weight Gain in Patients Taking Dolutegravir-Based Antiretroviral Therapy Without Concomitant Tenofovir Alafenamide ([VIRTUAL]) - Dec 2, 2021 - Abstract #ASHP2021ASHP_720;
- | sildenafil / Generic mfg.
Journal: Polypharmacy and potential drug-drug interactions for people with HIV in the UK from the Climate-HIV database. (Pubmed Central) - Dec 2, 2021
Non-ARV use by PWHIV is high and increases with age. Treatment decisions for ageing PWHIV should consider guideline recommendations for comorbidities.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: In silico screening of phytochemical compounds and FDA drugs as potential inhibitors for NSP16/10 5' methyl transferase activity. (Pubmed Central) - Dec 1, 2021
To examine the effectiveness of the identified drugs versus COVID-19, further in vitro and in vivo studies are required. Communicated by Ramaswamy H. Sarma.
- |||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical: He also said "During the initial dolutegravir roll out, many women were effectively denied access to a superior antiretroviral therapy regimen", and that women with HIV deserve a seat at the table in developing policies that govern their access to drugs when safety signals occur. (Twitter) - Dec 1, 2021
- ||| Tivicay (dolutegravir) / ViiV Healthcare
Clinical: Despite updated guidance from WHO in 2019 recommending use in women of reproductive age, large disparities in DTG uptake persisted such that only 29% of female patients aged 16-49 years had initiated dolutegravir compared with 58% patients aged 16-49 years by March 2020 (cont'd) (Twitter) - Dec 1, 2021
- |||| Tivicay (dolutegravir) / ViiV Healthcare
Our paper, "Disparities in Dolutegravir Uptake Affecting Females of Reproductive Age With HIV in Low- and Middle-Income Countries After Initial Concerns About Teratogenicity" was published in @AnnalsofIM in time for World AIDS Day. Press release is here: https://t.co/8RLGRUBNUQ👇 (Twitter) - Dec 1, 2021
- ||| Tivicay (dolutegravir) / ViiV Healthcare
Disparities in Dolutegravir Uptake Affecting Females of Reproductive Age With HIV in LMICs After Initial Concerns About Teratogenicity... @AnnalsofIM https://t.co/MA7kKeztxU Important study by several colleagues including @cla_cor showing how policy impacts practice & outcomes. (Twitter) - Nov 29, 2021
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Clinical data, Journal, Real-world evidence: Using Climate-HIV to describe real-world clinical outcomes for people living with HIV taking dolutegravir-based regimens. (Pubmed Central) - Nov 29, 2021
High levels of virologic suppression and low rates of discontinuation of DBRs were seen in a large, diverse, UK-based population with HIV-1 infection. These findings are broadly consistent with efficacy data from phase III studies.
- || Tivicay (dolutegravir) / ViiV Healthcare
Enrollment closed: Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women (clinicaltrials.gov) - Nov 26, 2021
P=N/A, N=250, Active, not recruiting, Sponsor: ViiV Healthcare
These findings are broadly consistent with efficacy data from phase III studies. Recruiting --> Active, not recruiting
- | Trial completion date, Trial primary completion date: HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Nov 24, 2021
P1, N=200, Recruiting, Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Recruiting --> Active, not recruiting Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Aug 2022
- || ritonavir / Generic mfg.
Clinical, Journal: Associations between Antiretroviral Drugs on Depressive Symptomatology in Homogenous Subgroups of Women with HIV. (Pubmed Central) - Nov 24, 2021
Tenofovir (4 of 5 subgroups) followed by efavirenz, emtricitabine, stavudine, lopinavir, etravirine, nelfinavir, ritonavir, and maraviroc were the most common agents associated with depressive symptoms, although the pattern and directionality varied by subgroup...Unexpectedly, dolutegravir and raltegravir were not associated with depressive symptoms among any subgroup...We examined associations between ART-agents and depressive symptoms among similar subgroups of women with HIV from the Women's Interagency HIV Study. The patterns of associations depended on sociodemographic, clinical, and behavioral characteristics of women.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Substance use, Unlike Dolutegravir, is Associated with Mood Symptoms in People Living with HIV. (Pubmed Central) - Nov 24, 2021
We observed no differences between dolutegravir-treated and dolutegravir-naive PLHIV. Our data show that depressed and anxious moods and impulsivity are common in PLHIV and associate with substance use and not with dolutegravir use.
- || Tivicay (dolutegravir) / ViiV Healthcare
Also, ARV is a single drug or the class, so we shouldn't be calling a regimen ARV. Dolutegravir is an ARV. Complete regimens include 2 or more ARVs to make a persons' ART (also obviating HAART) (Twitter) - Nov 23, 2021
- || Tivicay (dolutegravir) / ViiV Healthcare
Trial initiation date: BMS02: Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana (clinicaltrials.gov) - Nov 23, 2021
P=N/A, N=200, Not yet recruiting, Sponsor: Duke University
Our data show that depressed and anxious moods and impulsivity are common in PLHIV and associate with substance use and not with dolutegravir use. Initiation date: Oct 2021 --> Feb 2022
- | Tivicay (dolutegravir) / ViiV Healthcare
Enrollment open: Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV (clinicaltrials.gov) - Nov 22, 2021
P2, N=30, Recruiting, Sponsor: Chulalongkorn University
Initiation date: Oct 2021 --> Feb 2022 Not yet recruiting --> Recruiting
- |||| bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Of course this integrase inhibitor drug class was just getting started. Look at on-treatment responses today using dolutegravir and bictegravir-containing regimens. And this with no treatment-emergent resistance 11/x (Twitter) - Nov 21, 2021
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Virological outcome and frequency of low-level viremia in patients receiving generic dolutegravir-containing regimen at a large tertiary care clinic in Western India. (Pubmed Central) - Nov 17, 2021
DTG is well tolerated and effective in suppressing HIV across all antiretroviral treatment categories. The rate of persistent LLV is low in DTG-containing therapy.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Patient experiences of switching from Efavirenz- to Dolutegravir-based antiretroviral therapy: a qualitative study in Uganda. (Pubmed Central) - Nov 17, 2021
DTG was nonetheless largely preferred because of the small pill size, once daily dosing, and absence of EFV-like side effects. Community-engaged research is needed to devise acceptable ways to prepare participants for switching ART at scale.
- | Journal: Changes in BMI associated with antiretroviral regimen switch among treatment-experienced, virologically suppressed people living with HIV in the United States. (Pubmed Central) - Nov 17, 2021
Gains were attenuated with a longer period of follow-up. BMI gains did not differ by regimens, except for bDRV regimens which were consistently associated with smaller BMI increases than DTG.
- | Tivicay (dolutegravir) / ViiV Healthcare
New P1/2 trial: Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS) (clinicaltrials.gov) - Nov 16, 2021
P1/2, N=92, Not yet recruiting, Sponsor: The Aurum Institute NPC
- | Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Changes in neurocognitive assessment scores after initiating dolutegravir- versus elvitegravir-based antiretroviral therapy. (Pubmed Central) - Nov 16, 2021
Of those on DTG, 8 (44%) had MoCA scores <26 on follow-up compared to 11 (65%) on EVG (p = 0.229). There were no significant differences in changes in any of the individual MoCA domains.
- | Tivicay (dolutegravir) / ViiV Healthcare
New P1/2 trial: DOLPHIN Moms: Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV (clinicaltrials.gov) - Nov 15, 2021
P1/2, N=252, Not yet recruiting, Sponsor: The Aurum Institute NPC
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Pre-treatment HIV Drug Resistance Among Adults Initiating or Re-initiating 1st Line Antiretroviral Therapy in Zimbabwe: Fast-tracking the Transition to Dolutegravir Based 1st Line Regimens? (Pubmed Central) - Nov 7, 2021
Our study shows that PDR to NNRTIs in Zimbabwe has remarkably increased from the 10.9% prevalence reported in the 2016 WHO survey. Addressing PDR at a national level is a critical need and will be facilitated by fast-tracking the transition to dolutegravir in 1st line ART regimens.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Apoptotic colitis owing to dolutegravir. (Pubmed Central) - Nov 6, 2021
Addressing PDR at a national level is a critical need and will be facilitated by fast-tracking the transition to dolutegravir in 1st line ART regimens. No abstract available
- || ondansetron / Generic mfg., cefuroxime / Generic mfg.
PK/PD data, Journal: Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics? (Pubmed Central) - Nov 5, 2021
In healthy pregnancies, differential protein binding characteristics in mother and fetus give rise to minor differences in maternal-fetal drug exposure. Further studies are needed to differentiate passive and active transfer processes across the apical and basolateral trophoblast membrane.