Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment

This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy

Start Date31 Jan 2025

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT06338826 / Not yet recruitingPhase 2IIT

Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses

The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy

Start Date01 Oct 2024

Sponsor / Collaborator

ANRS, Emerging Infectious Diseases

NCT05652478 / RecruitingPhase 2IIT

A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers

Background:
People with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.
Objective:
To see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be compared with a non-INSTI drug, tenofovir alafenamide (TAF).
Eligibility:
Healthy people aged 18 to 55.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.
Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with a 3-week break between.
Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug for 8 days during each stay.
Participants will have tests to see how their body uses energy:
They will spend 23 continuous hours in a special room that measures how much oxygen they breathe in and how much carbon dioxide they breathe out. They will do this a total of 6 times.
They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density.
They will lie on a table. Electrodes will be placed on their hands and feet to measure body fat and lean body mass.
They will stand still on a platform for about 30 seconds. High-resolution laser cameras will scan their bodies.

Start Date24 Sep 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Dolutegravir Sodium

100 Translational Medicine associated with Dolutegravir Sodium

100 Patents (Medical) associated with Dolutegravir Sodium

2,336

Literatures (Medical) associated with Dolutegravir Sodium

AIDS (London, England)

Dolutegravir induced neural tube defects in mice are folate responsive

Article

Author: Finnell, Richard H ; Wei, Hui ; Wlodarczyk, Bogdan J ; Tukeman, Gabriel L ; Cabrera, Robert M ; Lin, Ying L

Objectives:

In 2018, the Botswana Tsepamo Study reported a nine-fold increased risk of neural tube defects in infants whose mothers were treated with dolutegravir (DTG) from the time of conception. As maternal folate supplementation and status is a well-known modifier of neural tube defect (NTD) risk, we sought to evaluate birth outcomes in mice fed normal and low folic acid diets treated with DTG during pregnancy.

Design:

DTG was evaluated for developmental toxicity using pregnant mice fed normal or low folic acid diet.

Methods:

CD-1 mice were provided diet with normal (3 mg per kg) or low (0.3 mg per kg) folic acid. They were treated with water, a human therapeutic-equivalent dose, or supratherapeutic dose of DTG from mouse embryonic day E6.5 to E12.5. Pregnant dams were sacrificed at term (E18.5) and fetuses were inspected for gross, internal, and skeletal defects.

Results:

Fetuses with exencephaly, an NTD, were present in both therapeutic human equivalent and supratherapeutic exposures in dams fed low folic acid diet. Palate clefts were also found under both folate conditions.

Conclusions:

Recommended dietary folic acid levels during mouse pregnancy ameliorate developmental defects that arise from DTG exposure. Since low folate status in mice exposed to DTG increases the risk for NTDs, it is possible that DTG exposures in people living with HIV with low folate status during pregnancy may explain, at least in part, the elevated NTD risk signal observed in Botswana. Based on these results, future studies should consider folate status as a modifier for DTG-associated NTD risk.

01 Mar 2024·Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

Augmented least squares, a powerful chemometric approach for the spectroscopic analysis of the antiretroviral therapy abacavir, lamivudine and dolutegravir in their ternary mixture

Article

Author: Serag, Ahmed ; Gahtani, Reem M ; Alqahtani, Taha ; Abdelazim, Ahmed H ; Alqahtani, Ali

Augmented least squares models such as concentration residual augmented classical least squares (CRACLS) and spectral residual augmented classical least squares (SRACLS) are powerful chemometric approaches that can be applied for spectroscopic analysis of many pharmaceutical compounds. Herein, both CRACLS and SRACL have been employed for UV spectral analysis of three antiretroviral therapy namely abacavir (ACV), lamivudine (LMV) and dolutegravir (DTG) in their ternary mixture. A partial factorial design has been utilized for calibration set construction then both CRACLS and SRACLS models have been optimized regarding the number of iterations and principal components, respectively, using a leave-one-out cross-validation procedure. It was found that a higher number of iterations and principal components were required for modelling the minor component DTG indicating more augmentation procedures to improve the models' accuracy. Validation of the proposed models was performed using external validation set of 13 mixtures and different validation parameters have been evaluated regarding models' predictive abilities. Both models showed excellent performance for analyzing ACV and LMV with relative root mean square error of prediction (RRMSEP) below 2 %. However, higher RRMSEP values around 5 % were observed for the minor component DTG suggesting that these models should be utilized with caution when analyzing minor components in mixtures. Furthermore, the suggested models have been applied for analyzing ACV, LMV and DTG in their pharmaceutical formulation and excellent agreement was observed between the suggested models and the reported chromatographic method posing these models as powerful chemometric approaches for quality control analysis of many pharmaceutical compounds.

01 Mar 2024·Journal of pharmaceutical and biomedical analysis

Development and validation of an ultra-high performance liquid chromatography-tandem mass spectrometry method to quantify antiretroviral drug concentrations in human plasma for therapeutic monitoring

Article

Author: Devanathan, Aaron S ; Riddler, Sharon A ; Oberly, Patrick J ; Nolin, Thomas D ; West, Raymond E

Antiretroviral therapy (ART) is highly effective for the treatment of HIV-1 infection. ART previously consisted of concomitant administration of many drugs, multiple times per day. Currently, ART generally consists of two- or three-drug regimens once daily as fixed-dose combinations. Drug monitoring may be necessary to ensure adequate concentrations are achieved in the plasma over the dosing interval and prevent further HIV resistance formation. Additionally, nonadherence remains an issue, highlighting the need to ensure sufficient ART exposure. Towards this effort, we developed and validated a highly selective ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous quantification of a panel of nine antiretrovirals: abacavir, bictegravir, cabotegravir, dolutegravir, doravirine, emtricitabine, lamivudine, raltegravir, and tenofovir in human plasma. Using only 50 µL of plasma, a simple protein precipitation with acetonitrile with internal standards followed by reconstitution in 50 uL (high) or 400 uL (low) was performed. Analyte separation was achieved using a multistep UPLC gradient mixture of (A: 0.1% formic acid in water and B: acetonitrile) and a Waters CORTECS T3 (2.1 ×100 mm) column. The method was comprehensively validated according to the United States Food and Drug Administration Bioanalytical Guidelines over two clinically relevant ranges (1-250 ng/mL and 100-5000 ng/mL) with excellent linearity (R² > 0.99 for all). The assay run time was 7.5 min. This method achieves acceptable performance of trueness (89.7-104.1%), repeatability, and precision (CV <15%), and allows for simultaneous quantification of guideline-recommended ART regimens. This method can be utilized for the therapeutic monitoring of antiretrovirals in human plasma.

News (Medical) associated with Dolutegravir Sodium

24 Jul 2024

·pmlive.com

GSK’s ViiV shares positive head-to-head results for two-drug HIV regimen Dovato

GSK’s ViiV Healthcare has shared positive results from a head-to-head study of its two-drug human immunodeficiency virus (HIV) regimen, Dovato (dolutegravir/lamivudine), in patients who are virologically suppressed. The phase 4 PASO DOBLE trial has been evaluating Dovato against Gilead Sciences’ three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as a maintenance therapy for HIV-1 in patients who could benefit from treatment optimisation, such as those on multiple tablets a day or taking drugs with cumulative toxicity. The study met its primary endpoint, with Dovato demonstrating non-inferior efficacy in maintaining viral suppression after 48 weeks of treatment compared to Biktarvy. At the time of analysis, 2.2% of Dovato-treated patients had viral RNA of 50 copies/ml or above, versus 0.7% for those receiving Biktarvy. Results also showed that patients who switched to Dovato experienced significantly less weight gain than those who were given Biktarvy, with an adjusted mean change in body weight of 0.89kg and 1.81kg for the two cohorts, respectively, after 48 weeks. “This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV,” said Harmony Garges, chief medical officer of ViiV, which is majority owned by GSK, with Pfizer and Shionogi as shareholders. The number of people living with a diagnosed HIV infection and accessing care in England rose from 91,368 in 2021 to 94,397 in 2022. Chief executive investigator of PASO DOBLE, Esteban Martínez, Hospital Clínic of Barcelona, said: “The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression. “The results from PASO DOBLE show Dovato, a two-drug regimen, not [only] demonstrated the same efficacy as a three-drug regimen but also showed less weight gain compared to [Biktarvy] through 48 weeks.” Dovato already holds approvals to treat HIV-1 in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato.

Clinical ResultPhase 3

23 Jul 2024

·www.businesswire.com

ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for maintenance therapy of HIV-1

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announces 48-week findings from PASO DOBLE (GeSIDA 11720 study), the largest head-to-head, phase IV randomised clinical trial (RCT) investigating the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared to the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the treatment of HIV-1 in people who are virologically suppressed and who could benefit from treatment optimisation. 1 Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. 1 These data will be presented at the 25 th International AIDS Conference (AIDS 2024), held in Munich, Germany (22-26 July). Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “ The results from PASO DOBLE show that Dovato demonstrated non-inferior efficacy compared to Biktarvy , and that the average weight gain for trial participants taking DTG/3TC was significantly lower than those taking BIC/FTC/FTC over the course of the year. This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV. At ViiV Healthcare we're dedicated to bringing innovative HIV treatments to people living with HIV that are not only safe and effective, but also address their specific needs beyond viral suppression.” In the PASO DOBLE clinical trial, 553 people living with HIV and virally suppressed switched treatment to either DTG/3TC (n=277) or BIC/FTC/TAF (n=276). 1 The study population included individuals who were on therapy that could be optimised, such as multiple tablet regimens, or those containing pharmacokinetic boosting agents or drugs with cumulative toxicity, such as efavirenz or tenofovir disoproxil fumarate (TDF). 2 The study met its primary endpoint when DTG/3TC demonstrated non-inferior efficacy versus BIC/FTC/TAF based on the proportion of participants with viral RNA ≥50 copies/mL at 48 weeks using the FDA snapshot and a 4% non-inferiority margin in the exposed intention-to-treat population. 1 At 48 weeks, DTG/3TC was non-inferior to BIC/FTC/TAF (risk difference between DTG/3TC [2.2%] minus BIC/FTC/TAF [0.7%] of 1.4%, 95% CI -0.5 to 3.4). One participant in the BIC/FTC/TAF arm and zero in the DTG/3TC arm had protocol-defined confirmed virological failure through week 48 (HIV-1 RNA ≥50 c/mL followed by a second consecutive HIV-1 RNA assessment ≥200 c/mL). 1 The study found in a key secondary endpoint that weight increased significantly more in participants who switched to BIC/FTC/TAF (adjusted mean change 1.81kg, 95% CI 1.28-2.34) than in those who switched to DTG/3TC (adjusted mean change 0.89kg, 95% CI 0.37-1.41) [difference 0.92kg, 95% CI 0.17-1.66] through week 48. Equally, the proportion of participants with weight gain greater than 5% at week 48 was significantly higher at 29.9% for BIC/FTC/TAF compared to 20% for DTG/3TC (adjusted OR 1.81, 95% CI 1.19-2.76). 1 Weight change with DTG/3TC did not differ between men and women or based on the previous regimen of participants, whereas the proportion of trial participants experiencing greater than 5% weight gain with BIC/FTC/TAF was approximately 45% higher than those taking DTG/3TC when switching from a regimen with abacavir (30.6% BIC/FTC/TAF vs 21.1% DTG/3TC), and about 2-fold higher when switching from a regimen with TDF (40.7% BIC/FTC/TAF vs 19.5% DTG/3TC). Safety was comparable through week 48 and consistent with known safety profiles. There were few discontinuations due to adverse events in both study arms (DTG/3TC = 1, 0.4%; BIC/FTC/TAF = 2, 0.7%), with no differences between arms. 1 Esteban Martínez, MD, PhD, Chief Executive Investigator of the PASO DOBLE study and Senior Consultant in Infectious Diseases at Hospital Clínic of Barcelona, Spain said: “ The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression. The results from PASO DOBLE show Dovato , a 2-drug regimen, not just demonstrated the same efficacy as a 3-drug regimen, but also showed less weight gain compared to BIC/FTC/TAF through 48 weeks.” About PASO DOBLE 1,2 The PASO DOBLE (NCT04884139) randomised clinical trial is a phase IV, open-label, randomised multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virologic suppression in people living with HIV-1, conducted in 30 sites across Spain. Virologically suppressed people living with HIV on regimens containing ≥1 pill/day, boosters, or drugs with cumulative toxicity such as efavirenz or TDF were eligible and were randomised (1:1) to switch to either DTG/3TC or BIC/FTC/TAF. The primary endpoint was the proportion of people living with HIV with RNA ≥50 copies/mL at 48 weeks (FDA snapshot, 4% non-inferiority margin) in the intention-to-treat exposed population. Secondary outcomes measured included, among others, absolute weight gain, BMI change, and the proportion of participants with weight change greater than 5%. About Dovato Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato . Dovato is approved in the US, Europe, Japan, Australia, and other countries worldwide. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets . Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About SEIMC-GeSIDA Foundation (FSG) The SEIMC-GeSIDA Foundation (FSG) was created to encourage, promote, and support scientific and technical research and development, training, and publication of findings in the field of clinical microbiology and infectious diseases and associated conditions. FSG was founded by investigators from the Spanish Society of Clinical Microbiology and Infectious Diseases as a tool to promote high-quality investigation in the field of HIV infection and other infectious diseases. The Foundation also aims to respond to the scientific concerns of the group’s members. FSG is composed of qualified professionals with experience in the field of clinical trials and multicentre studies. Its streamlined infrastructure facilitates performance of clinical studies and responds to the needs of investigators in terms of methodology/statistical analysis and of logistics and management of trials and other multicentre studies. We also provide staff to run events such as scientific meetings and conferences (national and international) and to organise courses, lectures, talks, seminars, round-table talks, and specialised workshops. For more information on the FSG, please visit https://fundacionseimcgesida.org/en/quienes-somos/ About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q1 Results for 2024. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: GSK plc 980 Great West Road Brentford, Middlesex United Kingdom TW8 9GS ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1 P. Ryan, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASODOBLE (GeSIDA 11720) randomised clinical trial. Presented at the 25th International AIDS Conference. July 2024 2 Clinical Trials.gov - DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: (PASO-DOBLE). Available at https://clinicaltrials.gov/ct2/show/NCT04884139 . Last accessed July 2024

Clinical ResultPhase 3Drug Approval

23 Jul 2024

·firstwordpharma.com

GSK's Dovato holds its ground against Biktarvy in HIV treatment face-off

As HIV drug developers seek to differentiate their therapies beyond viral suppression, ViiV Healthcare has launched a new offensive in the battle for market dominance.On Tuesday, GSK's HIV-focused unit reported results from a head-to-head trial showing that its two-drug regimen Dovato (dolutegravir/lamivudine) not only demonstrated non-inferiority against Gilead Sciences' three-drug regimen heavyweight Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as a maintenance therapy for HIV, but also suggested an ability to mitigate treatment-related weight gain.The Phase IV PASO DOBLE study enrolled 553 virologically suppressed adults living with HIV who were randomised to switch to either Dovato or Biktarvy. Those on regimens containing at least one pill a day, boosters or drugs with cumulative toxicity such as efavirenz or tenofovir disoproxil fumarate (TDF) were eligible to participate.The trial met its primary endpoint, demonstrating that Dovato was non-inferior to Biktarvy in maintaining viral suppression over 48 weeks of therapy.Specifically, 2.2% of participants in the Dovato arm had viral RNA ≥50 copies/mL at the 48-week mark, compared to 0.7% in the Biktarvy arm, according to results presented at the International AIDS Conference underway this week. The difference of 1.4% between the groups fell well within the predefined 4% non-inferiority margin.ViiV said one participant in the Biktarvy arm and none in the Dovato arm experienced protocol-defined confirmed virological failure over the 48-week timeframe.Weight gain gapMeanwhile, the study's key secondary endpoint revealed a significant difference in weight gain between the two regimens. Participants who switched to Biktarvy experienced an adjusted weight increase of 1.81 kg on average, compared to 0.89 kg among those who switched to Dovato. Moreover, a higher proportion of Biktarvy-treated participants (29.9%) experienced weight gain >5% compared to those on Dovato (20%), a difference that was also statistically significant."The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression," commented Esteban Martínez, chief executive investigator of the PASO DOBLE study. Harmony Garges, chief medical officer at ViiV, said "this is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV."The safety profiles were comparable between the two regimens, with few dropouts due to adverse events in both study arms; one patient in the Dovato arm discontinued, versus two on Biktarvy.Dovato generated sales of £1.8 billion ($2.3 billion) in 2023, up 32% from the previous year. Meanwhile, Biktarvy, Gilead's top-selling product, reached sales of $11.8 billion last year, up 14% from 2022.

Clinical ResultPhase 3Phase 2

100 Deals associated with Dolutegravir Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D10113	Dolutegravir Sodium	J05AX12	DB08930

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	US	ViiV Healthcare Co.	12 Aug 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tuberculosis	Phase 3	BR	ViiV Healthcare Ltd.	31 Jan 2025
Pregnancy	Phase 3	ZA	ViiV Healthcare Ltd.	14 Mar 2017
Pregnancy	Phase 3	UG	ViiV Healthcare Ltd.	14 Mar 2017
Latent Tuberculosis	Phase 2	US	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	BW	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	HT	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	MW	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	ZA	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	TH	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	ZW	ViiV Healthcare Ltd.	27 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03991013 (ARTIST, CTgov)	Phase 2	HIV Infections	192	Dolutegravir 50 mg (Supplementary Dose)	irxvocbkby(soolcrrlbr) = ezemwptudk fnnodnlmgz (nbrpwtgtrv, dxabvpfgsq - xengijvqnu) View more	-	09 Aug 2024
				Placebo (Placebo Dose)	irxvocbkby(soolcrrlbr) = gzqkvsnyer fnnodnlmgz (nbrpwtgtrv, dskhntobbt - mehdvvqbje) View more
NCT03017872 (D2EFT, Pubmed)	Phase 4	Second line HIV RNA load	828	ritonavir-boosted darunavir plus two NRTIs	qwwcqkayiz(atqwnyqwdj) = itbdplphpf vyrrslnlrz (drghkupwkw )	Positive	01 Jul 2024
				ritonavir-boosted darunavir plus dolutegravir	qwwcqkayiz(atqwnyqwdj) = nwbnljqsio vyrrslnlrz (drghkupwkw )
NCT04857892 (CTgov)	Phase 1	HIV Infections	41	GSK3640254+DTG (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)	vfhrfcygwx(heerhvvvrg) = znskwtclnu aqlltwakks (djrigxuktz, gvwcdhcrvs - nishtkdmfm) View more	-	11 Mar 2024
				GSK3640254+DTG (Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))	vfhrfcygwx(heerhvvvrg) = bpjfzjizbe aqlltwakks (djrigxuktz, rjxtpagblr - cadyfrrmou) View more
NCT01837277 (IDEA, CTgov)	Phase 2/3	Acquired Immunodeficiency Syndrome	186	Dolutegravir 50 mg (Dolutegravir)	uatshiucdq(braxylnloy) = aveqnamwft fdplwvlgoa (uuyjqbztai, rruzoialwa - vbaxgaezwi) View more	-	14 Dec 2023
				Efavirenz-based regimens (Efavirenz)	uatshiucdq(braxylnloy) = ivypydhtwu fdplwvlgoa (uuyjqbztai, zxjiwiixuh - deritotsat) View more
NCT02777229 (NAMSAL-ANRS-12313, Pubmed \| Open Forum Infect Dis)	Phase 3	HIV Infections First line	613	Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	crxvvobujq(aohfkocitf) = bxfcqbfuie vefqcnudes (blprudiqhu ) View more	Positive	01 Dec 2023
				Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	crxvvobujq(aohfkocitf) = rqngqjbyvs vefqcnudes (blprudiqhu ) View more
NCT03851588 (RADIANT-TB, CTgov)	Phase 2	Tuberculosis \| HIV Infections	108	Dolutegravir 50 mg (Supplementary Dose)	cmoyhdsyfj(xbxoquwovq) = clrnkpqdrl vfwxgfqeor (twtsmzdfqr, zndddxhpac - qnvbjnxskb) View more	-	18 Sep 2023
				Placebo (Placebo Dose)	cmoyhdsyfj(xbxoquwovq) = dqyfkbwwgn vfwxgfqeor (twtsmzdfqr, fredsscddk - hapqkselmc) View more
NCT03224338 (Phase 2 Study, Pubmed \| Clin Infect Dis)	Phase 2	First line	30	Dolutegravir plus 2 NRTIs	yeaujvarue(jaoegyyeiv) = One participant discontinued due to central nervous system symptoms zjfxzycbmr (kbftcjlbqs ) View more	Positive	11 Sep 2023
NCT03851588 (RADIANT-TB, Pubmed)	Phase 2	Tuberculosis First line plasma HIV-1 RNA \| CD4 count	108	Tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus supplemental 50 mg dolutegravir	yivzswawej(gybkuwgfmk) = brurptsqhg zpwwsnmbhu (otyislpwrn, 70 - 92)	Positive	01 Jul 2023
				Tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus matched placebo	yivzswawej(gybkuwgfmk) = xkvkqpsuuk zpwwsnmbhu (otyislpwrn, 70 - 92)
ARTIST (Pubmed)	Not Applicable	Second line	62	Tenofovir, lamivudine/emtricitabine, and NNRTI	leqczhljbc(evkuspajxo) = dpmdiwowke njcppzmpgc (mvtcplswih, 74 - 93)	-	25 Jan 2023
NCT03512964 (CTgov)	Not Applicable	HIV Infections	32	Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY]+Dolutegravir 50 MG	dxuqcfjway(jynivsmful) = rfinyknthq uncjcxcbyu (tgsaipvejv, hfnpqgfndc - qaoohvpcon) View more	-	27 Oct 2022

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