HIV
Conditions
Brief summary
The main objective of this study is to compare the tolerability and adherence to a new drug regimen of post-exposure prophylaxis (PEP) for HIV,
Interventions
DRUGTenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)
(TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets
DRUGelvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
Film-coated tablets of 150 mg of elvitegravir, cobicistat 150 mg, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil. One tablet once / day.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years * Have been exposed to HIV, non-occupational and meets the requirements of current recommendations to start with three antiretroviral drugs PEP * that adequately informed consent in writing to participate in the study and undergo testing and exploration that entails
Exclusion criteria
* pregnant women, lactating, or those intend become pregnant during the study period. * subjects who are known or suspected case presents the source resistors to one of the drugs of the pattern of study * contraindicated treatment with the study drugs, or products under investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason | Twenty Eigth days | A subject is considered to abandon treatment if within 28 days * dies * Do not come to visit week 4 * changed or discontinued study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinical adverse events and / or laboratory alterations. | twenty-four weeks | — |
| Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up | twenty four weeks | — |
| degree of adhesion during the treatment period | twenty eight days | Measured by pill count and patient adherence questionnaire |
| time to loss of adherence to TARV | twenty eight days | — |
| Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up. | twenty four weeks | — |
Countries
Spain
Outcome results
None listed