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PRO 2000/5

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9,404

FDA Designations

No designations recorded

Clinical trial landscape

PRO 2000/5 · 1 trial · 4 indications

Phase 3 1
NCT00262106Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV InfectionHIV Infections
COMPLETED9,404 Analytics
PHASE3COMPLETED
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
HIV Infections
NCT002621069,404
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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
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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
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Eligibility Criteria

Age Range16 Years to 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
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Competitive Landscape -Bacterial Infections 61 trials (matched to "HIV Infections")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
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
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Frequently asked questions about PRO 2000/5

What is PRO 2000/5 used for?

PRO 2000/5 is an investigational small molecule being developed for the prevention of vaginally acquired HIV infection. It was evaluated in a Phase 3 clinical trial that also assessed its effects on gonorrhea, chlamydial infections, and genital herpes. The drug is not approved and remains in clinical development.

Who makes PRO 2000/5?

PRO 2000/5 is being developed by United Therapeutics Corporation, which trades on the NASDAQ under the ticker symbol UTHR. The company sponsored a Phase 3 clinical trial of the drug for the prevention of HIV infection.

What phase is PRO 2000/5 in?

PRO 2000/5 is in Phase 3 clinical development. A Phase 3 trial, NCT00262106, has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PRO 2000/5 in?

PRO 2000/5 was studied in one completed Phase 3 trial, NCT00262106, titled 'Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection.' The trial enrolled 9,404 female participants in South Africa, Tanzania, Uganda, and Zambia.

Is PRO 2000/5 the same as PRO 2000?

PRO 2000/5 is a specific formulation of the PRO 2000 compound. The clinical trial NCT00262106 evaluated PRO 2000/5 gels for the prevention of vaginally acquired HIV infection. No other alternative names for this drug have been disclosed.