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AMD11070

Phase 1

HIV Infections | Small molecule | Infectious Disease |Sanofi|Last Updated: Feb 11, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

AMD11070 · 1 trial · 2 indications

Phase 1 1
NCT00361101A Study of AMD11070 in HIV-infected Patients Carrying X4-tropic VirusHIV Infections
COMPLETED10 Analytics
PHASE1COMPLETED
A Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

safety and antiviral activity of AMD11070 administered in HIV-infected patients who harbor-X4-tropic virus.
10 days
the proportion of patients per cohort who have a ≥1 log10 rlu reduction in X4-tropic virus and to describe changes from baseline to Day 10 in log10 rlu corresponding to X4-tropic virus.
10 days

Secondary Endpoints

the relationship between standard pharmacokinetic (PK) measures, viral response, and a shift in T-cell receptor tropism.
10 days
the relationship of coreceptor tropism phenotype to CD4+ count, viral load, and drug resistance in the screening patient population.
10 days
the virologic activity of AMD11070 at day 10 of study treatment by analyzing the proportion of patients with Plasma HIV-1 RNA levels <400 and <50 copies/ml and the proportion with a >1 log10 decline in plasma HIV from baseline.
10 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
AMD11070DRUG200 mg PO BID (by mouth two times per day) for 10 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * HIV-1 infection, as documented by any licensed ELISA test kit (confirmed by Western Blot), HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, cDNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. * Both antiretroviral trea...

Countries:United StatesUnited Kingdom
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Frequently asked questions about AMD11070

What is AMD11070 used for?

AMD11070 is an investigational small molecule being studied for the treatment of HIV infections, specifically in patients carrying X4-tropic virus. It is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing AMD11070?

AMD11070 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials for HIV infections.

What phase is AMD11070 in?

AMD11070 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for its potential to treat HIV infections in patients with X4-tropic virus.

What clinical trials is AMD11070 in?

AMD11070 has one completed Phase 1 clinical trial, identified as NCT00361101. This study enrolled 10 participants and was conducted in the United States and United Kingdom. The trial focused on HIV-infected patients carrying X4-tropic virus.

Is AMD11070 FDA approved?

AMD11070 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for HIV infections. The drug has not completed the clinical trial process required for regulatory approval.