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zidovudine and lamivudine

Phase 3

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jul 4, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment220
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00323544SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV InfectionPHASE3 COMPLETED 220 — — Oct 1, 2004Oct 1, 2007Jul 4, 20081 United Kingdom
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Study Endpoints
Primary Endpoints
The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.
Secondary Endpoints
The secondary endpoints in this study include: Change from baseline in absolute haemoglobin at Week 48
Lipids profile: change from baseline in total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), TC/HDL, and triglyceride (TG)
Quality of life (QoL)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
zidovudine and lamivudine (Combivir®)DRUG -
emtricitabine and tenofovir DFDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients of either sex aged \> 18 years. 2. HIV positive. 3. Stable antiretroviral therapy consisting of efavirenz (EFV) given with Combivir® or zidovudine (AZT) + lamivudine (3TC) for at least 6 months. 4. Patients with viral loads \< 50 copies/ml on last 2 consecutive tests...

Countries:United Kingdom
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Competitive Landscape -Bacterial Infections 62 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15, ATM-AVI, BAT, Part A: ATM-AVI Single Dose, Cohorts 1-4, PG4 vaccine in Buffer 1 with low dose PA-001
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GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine, iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY
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CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
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Innoviva, Inc.INVA3PHASE2Eravacycline /kg, Sulbactam /kg -Durlobactam /kg
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Merck & Co., Inc.MRK2PHASE1V118C, PCV20
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ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Moderna, Inc.MRNA1PHASE2mRNA-1982
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 — AIGIV, CYFENDUS, Collection of samples
Abbott LaboratoriesABT1NAUndisclosed
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