HIV Infections Clinical Trial
Official title:
Phase II Clinical Trial to Analyze the Safety and Efficacy of Vedolizumab Combined With Antiretroviral Therapy to Achieve Permanent Virological Remission in HIV-infected Subjects Without Previous Antiretroviral Therapy
HIV cannot be eliminated and remains in the body despite the treatment that is used for HIV-infection called antiretroviral treatment (ART). Individuals undergoing ART interruption rapidly experience virus rebound in the blood. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the elimination of the virus in blood in the absence of ART. New drugs associated to ART that allow the elimination of the virus in the blood after ART withdrawn are needed. In monkeys infected with SIV, the analog of HIV, the virus has disappeared from the blood after administration of a compound and cessation of ART. There is an equivalent compound in humans called Vedolizumab. The aim of the present study is to research if Vedolizumab combined with ART, in subjects without previous ART, is able to eliminate the virus from the blood after ART is not taken.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Individuals with documented HIV-infection. Aged, 18 - 65 years. - HIV-RNA >1x10e4 copies/mL. - CD4+ T-cell counts >350 cells//µL - To accept analytical ART interruption. Exclusion Criteria: - Presence of major resistance mutations to the antiretrovirals used. - Active opportunistic infections. - Pregnancy or breastfeeding - Active hepatitis C or B virus infection. - Active or latent tuberculosis not treated. - Cirrhosis, portal hypertension and/or hypersplenism of any etiology. - Current or past neoplasia susceptible to be treated with steroids, immunotherapy or chemotherapy. - Abnormal laboratory measurements grade 3 or 4. - Concomitant use of drugs with pharmacological interactions with the treatment of the study based on the technical data sheet of the products. - Creatinine clearance <50mL/min. - Any type of vaccination (e.g., hepatitis B virus, influenza…) two weeks before the beginning of the study. - Cardiovascular disease (e.g., acute coronary syndrome, heart failure…). - Neurological or neuro psychiatric disorder which symptoms may interfere with the safety and tolerability analysis. - Alcohol abuse and/or drugs that may interfere with the study treatment. |
Country | Name | City | State |
---|---|---|---|
Spain | Virgen del Rocío University Hospital | Seville |
Lead Sponsor | Collaborator |
---|---|
Hospitales Universitarios Virgen del Rocío | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
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Byrareddy SN, Arthos J, Cicala C, Villinger F, Ortiz KT, Little D, Sidell N, Kane MA, Yu J, Jones JW, Santangelo PJ, Zurla C, McKinnon LR, Arnold KB, Woody CE, Walter L, Roos C, Noll A, Van Ryk D, Jelicic K, Cimbro R, Gumber S, Reid MD, Adsay V, Amancha PK, Mayne AE, Parslow TG, Fauci AS, Ansari AA. Sustained virologic control in SIV+ macaques after antiretroviral and a4ß7 antibody therapy. Science. 2016 Oct 14;354(6309):197-202. — View Citation
Byrareddy SN, Kallam B, Arthos J, Cicala C, Nawaz F, Hiatt J, Kersh EN, McNicholl JM, Hanson D, Reimann KA, Brameier M, Walter L, Rogers K, Mayne AE, Dunbar P, Villinger T, Little D, Parslow TG, Santangelo PJ, Villinger F, Fauci AS, Ansari AA. Targeting a4ß7 integrin reduces mucosal transmission of simian immunodeficiency virus and protects gut-associated lymphoid tissue from infection. Nat Med. 2014 Dec;20(12):1397-400. doi: 10.1038/nm.3715. Epub 2014 Nov 24. — View Citation
Cicala C, Martinelli E, McNally JP, Goode DJ, Gopaul R, Hiatt J, Jelicic K, Kottilil S, Macleod K, O'Shea A, Patel N, Van Ryk D, Wei D, Pascuccio M, Yi L, McKinnon L, Izulla P, Kimani J, Kaul R, Fauci AS, Arthos J. The integrin alpha4beta7 forms a complex with cell-surface CD4 and defines a T-cell subset that is highly susceptible to infection by HIV-1. Proc Natl Acad Sci U S A. 2009 Dec 8;106(49):20877-82. doi: 10.1073/pnas.0911796106. Epub 2009 Nov 20. — View Citation
Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734. — View Citation
Guzzo C, Ichikawa D, Park C, Phillips D, Liu Q, Zhang P, Kwon A, Miao H, Lu J, Rehm C, Arthos J, Cicala C, Cohen MS, Fauci AS, Kehrl JH, Lusso P. Virion incorporation of integrin a4ß7 facilitates HIV-1 infection and intestinal homing. Sci Immunol. 2017 May 12;2(11). pii: eaam7341. doi: 10.1126/sciimmunol.aam7341. — View Citation
Pernas M, Tarancón-Diez L, Rodríguez-Gallego E, Gómez J, Prado JG, Casado C, Dominguez-Molina B, Olivares I, Coiras M, León A, Rodriguez C, Benito JM, Rallón N, Plana M, Martinez-Madrid O, Dapena M, Iribarren JA, Del Romero J, García F, Alcamí J, Muñoz-Fernández MÁ, Vidal F, Leal M, Lopez-Galindez C, Ruiz-Mateos E; ECRIS integrated in the Spanish AIDS Research Network. Factors Leading to the Loss of Natural Elite Control of HIV-1 Infection. J Virol. 2017 Dec 6. pii: JVI.01805-17. doi: 10.1128/JVI.01805-17. [Epub ahead of print] — View Citation
Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The number of adverse events and severity during Vedolizumab infusions and during all the follow up. | 48 weeks | |
Primary | Plasma viral load rebound or remision after interrupting Vedolizumab infusions and ART | Quantitative plasma viral load (Roche HIV-1 RNA Viral Load Assay) measured before and after interrupting Vedolizumab infusions and ART. | 48 weeks |
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