Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)

HIV Infection Clinical Trial

— RAL-PEP  

Official title:

Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576731
• Other study ID #: 2011-003799-35
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2012
• Last updated: March 31, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP).

Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe.

Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.

A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Potentially sexual exposition to HIV

Exclusion Criteria:

• Pregnancy

• Source case with antiretroviral resistances

• any treatment contraindicated with the drugs of study

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Tenofovir, Emtricitabine, Lopinavir/r
Combination drug
• Tenofovir, Emtricitabine, Raltegravir
Combination drug

Locations

Country	Name	City	State
Spain	Hospital Clínic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients dropping out before the 28 days of postexposure prophylaxis	Proportion of patients droppping out before the 28 days of postexposure prophylaxis considering death, lost to folow-up and stopping or changing treatment for any reason	28 days	Yes