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raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

Phase 3

HIV-1 Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Trials Updated: Feb 5, 2014

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Dec 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine clinical trials

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine · 1 trial · 1 indication

Phase 3 1
NCT01033760Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)HIV-1 Infections
COMPLETED90 Analytics
PHASE3COMPLETED
Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
HIV-1 InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection
24 months

Secondary Endpoints

Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30
30 months
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24
24 months
Changes in cell-associated HIV-DNA between baseline and M24
24 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
arm 1EXPERIMENTALdarunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
arm 2ACTIVE_COMPARATORdarunavir, ritonavir, emtricitabine/tenofovir

Interventions

NameTypeDescription
raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabineDRUGraltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
darunavir; ritonavir; emtricitabine/tenofovirDRUGdarunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with acute or primary HIV-1 infection * Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24. * Primary infection: positive Elisa with incomplete Western-blot (≥ 2 ...

Countries:France
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Frequently asked questions about raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

What is the raltegravir, maraviroc, darunavir, ritonavir, and tenofovir/emtricitabine regimen used for?

This combination regimen is used to treat HIV-1 infection. It combines five antiretroviral agents from different classes: raltegravir, maraviroc, darunavir, ritonavir, and tenofovir/emtricitabine. The regimen was studied in a Phase 3 trial in France in adults with primary HIV-1 infection, which is the early stage after initial infection.

Who is developing the raltegravir, maraviroc, darunavir, ritonavir, and tenofovir/emtricitabine regimen?

Gilead Sciences, Inc. (ticker GILD) is the developer associated with this regimen. The combination brings together several small molecule antiretroviral agents, including tenofovir/emtricitabine, which is a Gilead product. The regimen was evaluated in a Phase 3 study conducted in France.

What phase is the raltegravir, maraviroc, darunavir, ritonavir, and tenofovir/emtricitabine regimen in?

The regimen has been studied in a Phase 3 clinical trial, which is now completed. It is an investigational combination for HIV-1 infection and is not described here as an approved product. The Phase 3 trial enrolled 90 participants and was active controlled.

What clinical trial studied the raltegravir, maraviroc, darunavir, ritonavir, and tenofovir/emtricitabine regimen?

The regimen was studied in NCT01033760, titled Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM). This Phase 3 trial enrolled 90 adults aged 18 years and older with HIV-1 infection in France. It was randomized, active controlled, and has been completed.

How does the raltegravir, maraviroc, darunavir, ritonavir, and tenofovir/emtricitabine regimen work?

The regimen combines five small molecule antiretroviral agents that act on different steps of the HIV-1 lifecycle. Raltegravir is an integrase inhibitor, maraviroc is a CCR5 antagonist, darunavir is a protease inhibitor boosted by ritonavir, and tenofovir/emtricitabine are nucleoside/nucleotide reverse transcriptase inhibitors. Combining classes targets the virus at multiple points.