None listed
Conditions
Interventions
Co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
(STRIBILD®) or emtricitabine/tenofovir disoproxil fumarate/efavirenz (Atripla™). When
STRIBILD and AtriplaTM are
Sponsors
Centro de Investigacion del Cancer Fred Hutchinson, Estados Unidos,
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In Step 1, potential participants must be MSM and transgender women , have sex with men, HIV status, at high-risk for HIV acquisition. Each potential participant must have the ability and willingness to provide informed consent for study participation, including being tested for HIV-1. If HIV infection is not diagnosed, he must be willing to be enrolled in Step 2, and if diagnosed with acute or recent HIV infection be willing to consider participation in Step 3. In particular, if they are HIV seronegative on antibodies analysis, but with evidence of acute infection (HIV-1 RNA-positive confirmed by HIV antigen analysis), they should be willing to be re-contacted for further HIV testing and linkage to care. In Step 2, volunteers who were found to have no HIV infection from Step 1 will be re-tested at variable times for incident HIV-1. Roughly, we anticipate testing 800 MSM and transgender women per month and follow-up until July 2015. In Step 3, men with acute or recent HIV-1 infection detected at Step 1 or Step 2; or individuals who have been diagnosed with HIV in any health clinic or laboratory authorized by the Ministry of Health, and that have had a documented negative result in the past three months with no prior ART exposure, with normal hematological, renal and liver function, will be enrolled in a randomized clinical trial for immediate vs. deferred ART, unless ART initiation criteria are met earlier.
Exclusion criteria
Exclusion criteria: Step 1: 1. Any medical, psychological/psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a participant’s ability to give informed consent; 2. Seeking HIV test behavior for routine reasons. 3. Use of estrogens (or its derivatives) or anti-androgens, administered orally or intramuscularly, during the past three months. Step 2: Any medical, psychological/psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a participant’s ability to give informed consent; Step 3: 1. Presentation with WHO clinical stage 3 or 4 irrespective of CD4 count. 2. Estimated creatinine clearance below 70 mL per minute 3. Use within 21 days prior to study entry of drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with lifethreatening adverse events or drugs that strongly induce CYP3A and lead to lower exposure of one or more components and loss of efficacy of STRIBILD and possible resistance: alfuzosin, astemizole cisapride, ergot aklaloids and derivatives, flecainide, St. John’s wort, lovastatin, simvastatin, triazolam, oral midazolam, pimozide, propafenone, rifampin, simvastatin, sildenafil terfenadine, and fluticasone-containing antigen) confirmed by a second virological test obtained from a separate determination. Test and Treat Early HIV among MSM and Transgender Women in Lima, Peru Version 2.0 Page 36 of 85 15 October 2014 compounds.. Check the most recent co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STRIBILD®) or coformulated emtricitabine/tenofovir DF/efavirenz package inserts for other exclusionary medications. 4. Prior receipt of investigational anti-HIV vaccine. 5. Ongoing therapy with any of the following: a. Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed; b. Systemic chemotherapeutic agents; c. Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine; d. Immunomodulatory treatments including Interleukin-2; e. Investigational agents; 6. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations; 7. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements; 8. Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements; 9. Chronic (HBsAg positive, anti-HBc positive, Ig M anti-HBc negative, and anti-HBs negative) or acute (HBsAg positive, anti-HBc positive, Ig M anti-HBc positive, and anti- HBs negative) hepatitis B infection. 10. Use of estrogens (or its derivatives) or anti-androgens, administered orally or intramuscularly, during the past three months.
Countries
Peru
Contacts
Public ContactJessica Rios
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION
Outcome results
None listed