PROJECT ¿SABES?”

Not Applicable

Recruiting

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-066-14
• Lead Sponsor: Centro de Investigacion del Cancer Fred Hutchinson, Estados Unidos,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-27
• Study Completion: 2019-10-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 2138

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified