Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Germans Trias i Pujol Hospital |
---|---|
Information provided by: | Germans Trias i Pujol Hospital |
ClinicalTrials.gov Identifier: | NCT00808002 |
The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection.
This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.
Condition | Intervention | Phase |
---|---|---|
HIV HIV Infections |
Drug: Raltegravir Drug: Maraviroc BID Drug: Tenofovir/Emtricitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine. |
Estimated Enrollment: | 20 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Start ARV treatment with : Raltegravir BID + Tenofovir/Emtricitabine QD + Maraviroc BID
|
Drug: Raltegravir
Raltegravir 400 mg every 12 hours
Drug: Maraviroc BID
Maraviroc 300 mg every 12 hours
Drug: Tenofovir/Emtricitabine
Tenofovir/Emtricitabine 300/200 mg every 24 hours
|
2: Active Comparator
Start ARV treatment with : Raltegravir BID + Tenofovir/Emtricitabine QD
|
Drug: Raltegravir
Raltegravir 400 mg every 12 hours
Drug: Tenofovir/Emtricitabine
Tenofovir/Emtricitabine 300/200 mg every 24 hours
|
A reservoir of latently infected cells established early in infection may be involved in the maintenance of viral persistence despite continuous highly active antiretroviral therapy (HAART). This is likely to represent the major barrier to virus eradication in patients on successful combination antiretroviral therapy.
The majority of the viruses in the latent reservoir use CCR5 receptor during entry.
More recently, clear evidences for decay of this HIV-1 reservoir in patients who initiated antiretroviral therapy early in infection have been demonstrated. The treatment of acute infection may set the stage for subsequent attempts at eradication. To achieve this, more potent antiretroviral therapy and/or more potent antilatency therapies may be needed.
In contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell membrane, nor does not require intracellular processing in order to exert its activity. In addition, there is no cross-resistance between entry inhibitors and agents that act on intracellular targets.
Maraviroc has demonstrated potent antiviral activity against all CCR5-tropic HIV-1 viruses tested. Maraviroc could thus fulfil the requirements for an optimal candidate for treatment intensification in HIV-1 infected patients with a recent HIV-1 infection.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bonaventura Clotet, MD,PhD | 0034934978887 | bclotet@flsida.org |
Spain | |
Hospital Clinic i Provincial de Barcelona | |
Barcelona, Spain, 08916 | |
Spain, Barcelona | |
Hospital Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 |
Principal Investigator: | Bonaventura Clotet, MD,PhD | LLuita contra la SIDA Foundation-HIV Unit |
Principal Investigator: | Josep Mª Llibre, MD,PhD | LLuita contra la SIDA Foundation-HIV Unit |
Responsible Party: | Lluita Sida Foundation ( Fundació LLuita contra la SIDA ) |
Study ID Numbers: | MARAVIBOOST |
Study First Received: | December 12, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00808002 |
Health Authority: | Spain: Ministry of Health |
Maraviroc CCR5 antagonists Primary HIV Infection |
HIV-1 reservoir eradication treatment naive |
Virus Diseases Sexually Transmitted Diseases, Viral Emtricitabine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |