Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
This study is currently recruiting participants.
Verified March 2013 by Hospital Clinic of Barcelona
Sponsor:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01576731
First received: April 3, 2012
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Tenofovir, Emtricitabine, Lopinavir/r Drug: Tenofovir, Emtricitabine, Raltegravir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Ritonavir
Lopinavir
Tenofovir Disoproxil Fumarate
Raltegravir
Raltegravir potassium
U.S. FDA Resources
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Proportion of patients dropping out before the 28 days of postexposure prophylaxis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 189 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Potentially sexual exposition to HIV
Exclusion Criteria:
- Pregnancy
- Source case with antiretroviral resistances
- any treatment contraindicated with the drugs of study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576731
Contacts
| Contact: García NA Felipe, MD | +34932275400 ext 2884 | fgarcia@clinic.ub.es |
Locations
| Spain | |
| Hospital Clínic of Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: García Felipe, MD +34932275400 ext 2884 fgarcia@clinic.ub.es | |
| Principal Investigator: García Felipe, MD | |
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
| Principal Investigator: | Felipe Garcia, PhD | Consultant senior |
More Information
No publications provided
| Responsible Party: | Felipe Garcia, MD, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT01576731 History of Changes |
| Other Study ID Numbers: | 2011-003799-35 |
| Study First Received: | April 3, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinic of Barcelona:
|
HIV Infection Postexposure prophylaxis |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Lopinavir Tenofovir |
Tenofovir disoproxil Emtricitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013