raltegravir
DrugRaltegravir 400 mg every 12 hours
NCT Number: 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.
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Notify Me18 year–99 year
All sexes
Interventional
Phase 3
Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Raltegravir 400 mg every 12 hours
Maraviroc 300 mg every 12 hours
Tenofovir/Emtricitabine 300/200 mg every 24 hours
Time frame: BL, W2, W4, W12, W24, W48
Time frame: BL, W2, W4, W8, W12, W24, W36, W48
Time frame: From Baseline to W48
Time frame: W48
Time frame: BL, W4, W12, W24, W48, W60, W72
Time frame: W12, W24, W48
Time frame: BL, W24, W48, W60, W72
Time frame: BL, W2, W4, W12, W48, W60
Time frame: W48
Time frame: W48
Time frame: W48
Germans Trias i Pujol Hospital
Other
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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