Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP) (RAL-PEP)
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ClinicalTrials.gov Identifier: NCT01576731 |
Recruitment Status
:
Completed
First Posted
: April 12, 2012
Last Update Posted
: April 1, 2015
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Tenofovir, Emtricitabine, Lopinavir/r Drug: Tenofovir, Emtricitabine, Raltegravir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tenofovir + emtricitabine + lopinavir/r
Standard postexposure prophylaxis combination
|
Drug: Tenofovir, Emtricitabine, Lopinavir/r
Combination drug
|
Experimental: Tenofovir + Emtricitabine + Raltegravir
new postexposure prophylaxis combination
|
Drug: Tenofovir, Emtricitabine, Raltegravir
Combination drug
|
- Proportion of patients dropping out before the 28 days of postexposure prophylaxis [ Time Frame: 28 days ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Potentially sexual exposition to HIV
Exclusion Criteria:
- Pregnancy
- Source case with antiretroviral resistances
- any treatment contraindicated with the drugs of study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576731
Spain | |
Hospital Clínic of Barcelona | |
Barcelona, Spain, 08036 |
Principal Investigator: | Felipe Garcia, PhD | Consultant senior |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Felipe Garcia, MD, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT01576731 History of Changes |
Other Study ID Numbers: |
2011-003799-35 |
First Posted: | April 12, 2012 Key Record Dates |
Last Update Posted: | April 1, 2015 |
Last Verified: | March 2015 |
Keywords provided by Felipe Garcia, Hospital Clinic of Barcelona:
HIV Infection Postexposure prophylaxis |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir Raltegravir Potassium Emtricitabine |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors HIV Integrase Inhibitors Integrase Inhibitors |