Truvada

Manufactured by Gilead Sciences

Sourced in United States

Truvada is a lab equipment product manufactured by Gilead Sciences. It is a medication that contains two active ingredients: emtricitabine and tenofovir disoproxil fumarate. The core function of Truvada is to serve as an antiretroviral medication used in the treatment of HIV infection.

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Lab products found in correlation

Isentress, by Merck Group (3 mentions) Stocrin, by Merck Group (2 mentions) Tenofovir disoproxil fumarate tdf, by Gilead Sciences (1 mentions) Emtricitabine ftc, by Gilead Sciences (1 mentions) Raltegravir ral, by Merck Group (1 mentions) Emtricitabine, by Gilead Sciences (1 mentions) Thiazolyl blue tetrazolium bromide, by Merck Group (1 mentions) Cholesterol chl, by Avanti Polar Lipids (1 mentions) Atripla, by Bristol-Myers Squibb (1 mentions) Emtriva, by Gilead Sciences (1 mentions) Viread, by Gilead Sciences (1 mentions) Sustiva, by Bristol-Myers Squibb (1 mentions)

12 protocols using truvada

Antiretroviral Therapy Regimens Comparison

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Eligible patients were randomized 1 : 1 : 1 to LPV/r (co-formulated LPV 200 mg/ritonavir 50 mg two tablets twice daily) with TDF 300 mg/FTC 200 mg (Truvada, Gilead Sciences; Nycomed, Germany; Patheon, Canada; Cork, Ireland; one tablet daily with food) (control group); ABC (600 mg tablet) with ddI (enteric-coated capsule of 250 or 400 mg based on body weight) once daily fasting, and LPV/r twice daily (ABC/ddI group) or DRV 800 mg (Prezista, Janssen - Borgo S. Michele, Italy, two 400 mg tablets) boosted with ritonavir (100 mg tablet) and TDF/FTC (Truvada), all taken with food once daily (DRV group). Participants in the ABC/ddI group with chronic hepatitis B continued 3TC 150 mg after enrolment. All drugs were originators (donated by Gilead Sciences and Janssen) or WHO-prequalified generics provided by the National Programmes. Human leucocyte antigen B∗5701 routine screening was not performed because it was not recommended by WHO, was unavailable in the national laboratories and the allele have a low prevalence in the African population [13 (link)].

Ciaffi L., Koulla-Shiro S., Sawadogo A., le Moing V., Eymard-Duvernay S., Izard S., Kouanfack C., Ngom Gueye N.F., Fobang A.A., Reynes J., Calmy A, & Delaporte E. (2015). Efficacy and safety of three second-line antiretroviral regimens in HIV-infected patients in Africa. AIDS (London, England), 29(12), 1473-1481.

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Evaluating Truvada PrEP Effectiveness in GBMSM

Cited 2 times

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PROUD was an open-label waitlist design trial to evaluate the effectiveness of daily Truvada as PrEP. Recruitment took place from November 2012 to April 2014 at 13 sexual health clinics in England. Eligible participants were HIV-negative gay bisexual or other MSM (GBMSM) or TGW, who reported condomless anal sex in the last three months and anticipated it again in the next three months. Participants were randomised 1:1 to receive PrEP immediately (immediate arm) or to a deferred start after 12 months (deferred arm). PrEP was prescribed in the form of a single daily tablet containing tenofovir disproxil fumarate and emtricitabine (Truvada; Gilead Sciences, Foster City, CA, USA). However, on 13th October 2014 the trial steering committee recommended that deferred participants be offered PrEP due to early results demonstrating its effectiveness. The study design, results and the cohort’s baseline characteristics are reported elsewhere [5 (link), 24 (link)].

Arnold-Forster D., Horne R., Nutland W., Wayal S., Rayment M., Rae C., Desai M., Clarke A., Sullivan A., McCormack S, & Gafos M. (2022). Perceptions and Practicalities Influencing Pre-exposure Prophylaxis Adherence Among Men Who Have Sex with Men in England. AIDS and Behavior, 26(8), 2768-2782.

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STRIDE Study: ART Initiation for HIV-TB Coinfection

Cited 1 time

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The STRIDE study enrolled HIV-infected ART-naïve participants with confirmed or probable tuberculosis, stratified by screening CD4⁺ cell count of < or ≥ 50 cells/ mm³; eligibility criteria for the STRIDE study are described in detail elsewhere[2 (link)]. Confirmed TB was defined as detection of acid fast bacilli (AFB) in sputum smear or lymph node specimen, or a positive culture for Mycobacterium tuberculosis from sputum, lymph node, or another sterile site. Probable TB required clinician's assessment that signs and symptoms warranted empiric TB treatment. Participants were required to have received 1-14 days of rifamycin-based TB treatment at the time of study entry. Study-provided ART was 600 mg of efavirenz daily (Stocrin, donated by Merck) and a fixed-dose combination of emtricitabine 200 mg daily and tenofovir disoproxil fumarate 300 mg daily (Truvada, donated by Gilead Sciences). Participants were followed for 48 weeks after study entry. The study protocol was approved by an institutional review board or ethics committee at each participating site. The National Institutes of Health funded this study and provided study oversight.

Kendall M.A., Nyirenda M., Wu X., Ive P., Benson C.A., Andersen J.W., Swindells S., Sanne I.M., Havlir D.V, & Kumwenda J. (2014). Tuberculosis Immune Reconstitution Inflammatory Syndrome in A5221 STRIDE: Timing, Severity and Implications for HIV-TB programs. Journal of acquired immune deficiency syndromes (1999), 65(4), 423-428.

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Controlled PrEP Adherence Pharmacokinetics

Cited 1 time

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The Tenofovir Adherence to Rapidly Guide and Evaluate PrEP and HIV Therapy (TARGET) study (ClinicalTrials.gov #NCT0301260) was a three-arm randomized, open-label pharmacokinetic clinical trial among healthy adults enrolled in Thailand with controlled levels of PrEP adherence. The study protocol has been published previously [19 (link)]. Eligible volunteers without HIV or hepatitis B infection, aged 18–49 years, were randomized to receive 2 doses/week (Monday and Thursday), 4 doses/week (Monday, Wednesday, Friday, and Saturday), or 7 doses/week (once daily) of TDF 300 mg/FTC 200 mg (Truvada, Gilead Sciences) for 6 weeks, representing low, moderate, and perfect PrEP adherence, respectively. During the 6-week dosing phase, we performed directly observed therapy (DOT) for each study drug intake. All participants ingested their last dose at the beginning of week 7 and were followed for another 4 weeks during the drug washout phase.

Niu X., Kubiak R.W., Siriprakaisil O., Klinbuyaem V., Sukrakanchana P.O., Cressey R., Okochi H., Gandhi M., Cressey T.R, & Drain P.K. (2022). Tenofovir-Diphosphate in Dried Blood Spots vs Tenofovir in Urine/Plasma for Oral Preexposure Prophylaxis Adherence Monitoring. Open Forum Infectious Diseases, 9(8), ofac405.

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Antiretroviral Formulated Food Protocol

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Food formulated with antiretroviral individual drug was prepared as reported with elevated dose modifications (34 (link)). In brief, tablets of emtricitabine and tenofovir disoproxil fumarate (Truvada^®; Gilead Sciences) and raltegravir (Isentress^®; Merck) were crushed into fine powder and manufactured with TestDiet 5B1Q feed (Modified LabDiet 5058 with 0.12% amoxicillin) into 1/2” irradiated pellets. Final concentrations of drugs in the food were 4,800 mg/kg raltegravir, 1,560 mg/kg tenofovir disoproxil, and 1,040 mg/kg emtricitabine. The estimated drug daily doses were 768 mg/kg raltegravir, 250 mg/kg tenofovir disoproxil, and 166 mg/kg emtricitabine.

Cheng L., Ma J., Li G, & Su L. (2018). Humanized Mice Engrafted With Human HSC Only or HSC and Thymus Support Comparable HIV-1 Replication, Immunopathology, and Responses to ART and Immune Therapy. Frontiers in Immunology, 9, 817.

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First-line ART Regimen Alternatives

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The first-line ART regimen consisted preferably of tenofovir/emtricitabine (300 mg + 200 mg oad; Truvada®, Gilead Sciences, Inc.) plus efavirenz (600 mg tad; Stocrin®, Merck Sharp & Dohme Corp.) Patients with contraindications to efavirenz (patients dually infected with HIV-1 and HIV-2, women who did not use effective contraception or had a history of nevirapine monotherapy for pMTCT) received tenofovir/emtricitabine plus lopinavir–ritonavir (100 mg/400 mg tad), or tenofovir/emtricitabine plus zidovudine (300 mg tad). The latter regimen was abandoned in December 2008 due to increased side effects in the upper digestive tract [15 (link)].

Moh D.R., Ntakpé J.B., Gabillard D., Yayo-Emieme A.A., Badjé A., Kouame G.M., d’Aquin T.T., Danel C., Anglaret X, & Eholié S.P. (2022). Association of cellular HIV-1 DNA and virological success of antiretroviral treatment in HIV-infected sub-Saharan African adults. BMC Infectious Diseases, 22, 100.

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Exosome Therapy for HIV Latency

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Infected mice with detectable viremia were treated orally for two weeks with cART composed of drugs that block new infections. The cART regimen consisting of Truvada^® [tenofovir disoproxil fumarate (TDF; 300 mg/tablet), emtricitabine (FTC; 200 mg/tablet) (Gilead Sciences)] and Isentress® [raltegravir (RAL; 400 mg/tablet) (Merck)], scaled down to the equivalent mouse dosage using the appropriate conversion factor, was administered in a drinking water formulation (sweetened water gel, Medidrop® Sucralose, ClearH₂0). For 200 ml Medidrop^®, ½ Truvada tablet, and ½ Isentress tablet were crushed to powder, mixed by vigorous shaking, and changed weekly as per doses calculated previously⁶⁴. Mice were bled by retro-orbital bleeding, and peripheral blood cell populations and plasma viral loads were analyzed periodically using RT-qPCR. The oral cART regimen was withdrawn after two weeks and exosome treatment was initiated. Exosomes derived from HEK293T cells packed with nLuc, ZFP, or ZPAMt were retro-orbitally injected at a concentration of 100 × 10⁹ in 100 ul sterile PBS once a week for 6 weeks.

Shrivastava S., Ray R.M., Holguin L., Echavarria L., Grepo N., Scott T.A., Burnett J, & Morris K.V. (2021). Exosome-mediated stable epigenetic repression of HIV-1. Nature Communications, 12, 5541.

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Multimodal HIV Prevention Products Evaluation

Cited 2 times

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As shown in Figure 1, the products provided to study participants were oral tablets (representing a co-formulated tablet similar to Truvada™; Gilead Sciences, Foster City, CA, USA) similar to those being rolled out worldwide for oral pre-exposure prophylaxis (PrEP);16 a vaginal silicone elastomer ring similar to the dapivirine ring used in recent clinical trials for HIV prevention (International Partnership for Microbicides, Silver Spring, MD, USA);17 (link),18 (link) and two 2 mL saline injections as used in the HPTN-076 trial.19 These were intended to closely resemble products commercially available or in the development pipeline for HIV prevention and MPT.

Shapley-Quinn M.K., Manenzhe K.N., Agot K., Minnis A.M, & van der Straten A. (2019). “We are not the same”: African women’s view of multipurpose prevention products in the TRIO clinical study. International Journal of Women's Health, 11, 97-107.

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Oral ART Treatment in HIV-Infected Mice

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Infected mice with detectable viral infection (defined as >10³ cp/mL of HIV in blood) were treated orally for 3 weeks with ART composed of drugs that block new infections, without inhibiting viral production in infected cells. The ART regimen consisting of Truvada (tenofovir disoproxil fumarate [300 mg/tablet], emtricitabine [200 mg/tablet; Gilead Sciences, Foster City, CA]) and Isentress (raltegravir 400 mg/tablet (Merck, Kenilworth, NJ), scaled down to the equivalent mouse dosage using the appropriate conversion factor, was administered in a drinking water formulation (sweetened water gel, Medidrop Sucralose, ClearH20). For 400 mL Medidrop, ½ Truvada tablet, and ½ Isentress tablet were crushed to powder and mixed by shaking bottle to a homogenous solution; medicated water was changed weekly. Doses of ART drugs were calculated based on previous studies using the same delivery system.⁶⁴ (link)

Guan M., Lim L., Holguin L., Han T., Vyas V., Urak R., Miller A., Browning D.L., Echavarria L., Li S., Li S., Chang W.C., Scott T., Yazaki P., Morris K.V., Cardoso A.A., Blanchard M.S., Le Verche V., Forman S.J., Zaia J.A., Burnett J.C, & Wang X. (2022). Pre-clinical data supporting immunotherapy for HIV using CMV-HIV-specific CAR T cells with CMV vaccine. Molecular Therapy. Methods & Clinical Development, 25, 344-359.

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Placebo Pills and Vaginal Ring for PrEP

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Placebo pills for daily oral PrEP (identical in appearance to Truvada, Gilead Sciences, Foster City, CA, USA) and a silicone elastomer placebo ring (identical in appearance to dapivirine vaginal ring, International Partnership for Microbicides, Silver Spring, MD, USA) were presented for handling during FGDs.

van der Straten A., Ryan J.H., Reddy K., Etima J., Taulo F., Mutero P., Taylor J., Piper J, & Musara P. (2020). Influences on willingness to use vaginal or oral HIV PrEP during pregnancy and breastfeeding in Africa: the multisite MAMMA study. Journal of the International AIDS Society, 23(6), e25536.

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