Recent Updates
Recently added Catalysts

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

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 Infections
NCT0103376090
Unlock 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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Bacterial Infections 60 trials (matched to "HIV-1 Infections")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
GSK plc Sponsored ADRGSK3PHASE2MenABCWY vaccine
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
Unlock Competitive Intelligence