Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
This study is currently recruiting participants.
Verified February 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:
NCT01533272
First received: February 8, 2012
Last updated: February 21, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul be an adequate drug for PEP.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Tenofovir, emtricitabine, maraviroc Drug: Tenofovir, emtricitabine, lopinavir/r |
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+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC |
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
Maraviroc
U.S. FDA Resources
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Proportion of patients reaching 28 days of postexposure prophylaxis. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Postexposure prophylaxis has to be used during 28 days to have effectiveness. It is thought that a shorter period of treatment does not prevent HIV infection according to animal models. Therefore, we will assess the proportion of patients who complete the total period of treatment in each arm of the study. The hypothesis is that a higher proportion of patients who take the medication with lower side effects will complete the 28 days of postexposure prophylaxis
| Estimated Enrollment: | 189 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tenofovir, emtricitabine, Maraviroc
New postexposure prophylaxis (it is a combination drug)
|
Drug: Tenofovir, emtricitabine, maraviroc
experimental drug
|
|
Active Comparator: Tenofovir, emtricitabine, lopinavir/r
Standard prophylaxis (it is a combination drug)
|
Drug: Tenofovir, emtricitabine, lopinavir/r
Lopinavir/r 400mg BID
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Both sexes
- Older than 18 years old
- A potentially sexual exposition to HIV
- Accept to participate
Exclusion Criteria:
- Pregnant women
- The source case a person with HIV antiretroviral resistances
- Persons with a treatment that is contraindicated with the drugs in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533272
Contacts
| Contact: Felipe García, MD | 0034932275400 ext 2884 | fgarcia@clinic.ub.es |
Locations
| Spain | |
| Hospital Clinic de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Felipe García, MD +34932275400 ext 2884 fgarcia@clinic.ub.es | |
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
| Principal Investigator: | Felipe Garcia, PhD | Consultant |
More Information
No publications provided
| Responsible Party: | Felipe Garcia, PhD, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT01533272 History of Changes |
| Other Study ID Numbers: | MARAVI-PEP |
| Study First Received: | February 8, 2012 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Spain: Ministry of Health and Consumption |
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 March 14, 2013
