Comparison of two antiretroviral regimens in HIV Post-exposure Prophylaxis: TDF-FTC (Truvada®) + Lopinavir/ritonavir (kaletra®) versus TDF-FTC (Truvada®) + raltegravir (Isentress®)

- RAL-PEP

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003799-35-ES

Enrollment

189

Registered

2011-10-28

Start date

2012-01-05

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV- post exposition prophylaxis

Interventions

Trade Name: kaletra Pharmaceutical Form: Tablet INN or Proposed INN: LOPINAVIR CAS Number: 192725-17-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 years or older - HIV exposure requiring prophylaxis under current guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 189 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 189

Exclusion criteria

Exclusion criteria: - Pregnancy, nursing, or planned pregnancy during the study period - Suspected drug resistance in source case - Contraindications to the study drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the tolerability and patient adherence of two antiretroviral regimens in HIV Post-exposure Prophylaxis: Truvada® + Raltegravir vs. Truvada® + Lopinavir/ritonavir.;Secondary Objective: - To compare drop-outs rate - To compare the tolerability of a new regimen - To compare adherence to antiretroviral treatment - To compare HIV seroconversion;Primary end point(s): - Proportion of patients droping-out before completing 28-days antiretroviral treatment;Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

Main Objective: To compare the tolerability and patient adherence of two antiretroviral regimens in HIV Post-exposure Prophylaxis: Truvada® + Raltegravir vs. Truvada® + Lopinavir/ritonavir.;Secondary Objective: - To compare drop-outs rate - To compare the tolerability of a new regimen - To compare adherence to antiretroviral treatment - To compare HIV seroconversion;Primary end point(s): - Proportion of patients droping-out before completing 28-days antiretroviral treatment;Timepoint(s) of evaluation of this end point: 28 days

—

Secondary

Measure	Time frame
Secondary end point(s): - Incidence of adverse effects (clinical and laboratory) during antiretroviral treatment - Proportion of patients discontinuing antiretroviral regimen due to toxicity - Adherence to antiretroviral treatment - Time to adherence loss - Proportion of HIV-seropositive at 24 weeks;Timepoint(s) of evaluation of this end point: 28 days and 24 weeks	—

Countries

Spain

Contacts

Public ContactJudit Pich

CTU Clinic

jpich@clinic.ub.es+349322754002815

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026