Recent Updates
Recently added Catalysts

PRO 2000/5

Phase 3

HIV Infections | Small molecule | Infectious Disease |United Therapeutics Corporation|Last Updated: Sep 10, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9,404
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00262106Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV InfectionPHASE3 COMPLETED 9,404 — — Oct 1, 2005Sep 1, 2009Sep 10, 20126 South Africa, Tanzania +2
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Acquisition of HIV infection before or at the 12 month time point, confirmed in a central laboratory, in participants confirmed to be HIV negative at enrollment
12 months
Grade 3 (severe) or 4 (life-threatening) clinical or laboratory adverse event confirmed on examination or repeat testing, respectively
12 months
Secondary Endpoints
Acquisition of HIV infection before or at the 6, 9, or beyond 12 month time points, confirmed in a central laboratory, in participants confirmed to be HIV negative at enrollment
6, 9 and 12 months
HSV-2 incidence rates by the 9 month time point in participants uninfected at enrollment. Although prevalence rates are high, 75% - 85% in some sites, data from feasibility studies indicate that incidence rates are also likely to be high
9 months
HSV-2 incidence rates by the 12 month time point in participants uninfected at enrolment. Although prevalence rates are high, 75% - 85% in some sites, data from feasibility studies indicate that incidence rates are also likely to be high
12 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORplacebo
PRO 2000/5 Gel 0.5%ACTIVE_COMPARATORPRO 2000/5 Gel 0.5%
Interventions
NameTypeDescription
PRO 2000/5DRUGGel
PlaceboDRUGPlacebo
Unlock Study Design Details
Eligibility Criteria
Age Range16 Years — N/A
SexFEMALE
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Women aged 16 years and above at enrolment in Masaka and Mwanza, or aged 18 years and above at enrolment in the South African and Zambian sites * Likely to be sexually active at entry and during follow-up * Willing to undergo HIV testing at screening and approximately 12 weekl...

Countries:South AfricaTanzaniaUgandaZambia
Unlock Eligibility Criteria
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
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine, iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY
Zai Lab Ltd. Sponsored ADRZLAB1PHASE3Omadacycline, Moxifloxacin
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar, Sinovac PCV24, high-dose Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline /kg, Sulbactam /kg -Durlobactam /kg
BiomX LtdPHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
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
Unlock Competitive Intelligence