NCT00361101

Brief Summary

The purpose of this study is to determine the safety and activity of AMD11070 in HIV-infected patients carrying X4-tropic virus.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1 hiv-infections

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

August 3, 2006

Last Update Submit

February 10, 2014

Conditions

HIV InfectionsX4 Tropic Virus

Keywords

HIVX4 tropic virus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

  • changes in CD4+ cell counts and percentages on and off AMD11070.

    10 days

  • change from baseline in CD34+ cells

    10 days

Interventions

AMD11070DRUG

200 mg PO BID (by mouth two times per day) for 10 days.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 treatment-naïve and -experienced patients. Treatment-experienced patients currently on antiretroviral therapy are required to have a washout period of at least 14 days prior to study entry.
  • Presence of X4 tropic virus as determined by a luciferase activity of ≥2000 rlu on the HIV-1 coreceptor tropism assay from a sample collected no more than 56 days prior to study baseline.
  • Peripheral blood CD4+ cell count ≤200 cells/mm\^3.
  • Plasma HIV-1 RNA ≥5000 copies/ml by any standard assay.
  • Laboratory values prior to study entry: A. Absolute neutrophil count (ANC) ≥750/mm\^3. B. WBC ≥1500/mm\^3. C. Hemoglobin ≥10g/dL. D. Platelet count ≥80,000/mm\^3. E. Creatinine ≤ 1.2 x ULN. F. AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 1.5 x ULN. G. Total bilirubin ≤ 1.2 x ULN. Note: Except for patients who are on atazanavir or indinavir during screening. For these patients, total bilirubin ≤ 4.0 x ULN will be permitted. H. Serum lipase within normal limits. I. PT and PTT ≤ 1.2 x ULN. J. Calcium and magnesium within normal limits.
  • Female patients of reproductive potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/ml performed within 24 hours before study entry and initiation of the protocol-specified medication..
  • All patients must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
  • Willingness of female patients to discontinue hormonal contraception 1 week prior to study entry. Note: Female patients who discontinue hormonal contraception prior to study entry may resume hormonal contraception after study day 11.
  • Karnofsky performance score ≥90 at screening.
  • Ability and willingness of patient or legal guardian/representative to give written informed consent.

You may not qualify if:

  • Patients with a known sensitivity to AMD11070 and its excipients (cellulose, croscarmellose, sodium stearyl fumarate, silicone dioxide, calcium phosphate dihydrate,sodium lauryl sulfate).
  • Pregnancy or breast-feeding.
  • Any antiretroviral treatment within 14 days prior to study entry.
  • Any immunizations within 30 days prior to study entry.
  • Treatment with radiation therapy or cytotoxic chemotherapy agents or immuno-modulating agents within 30 days prior to study entry.
  • Use of contraindicated prescription medications, herbal supplements, or aspirin within seven days prior to study entry.
  • Use of any CYP-3A4 inhibitors or inducers, and P-gp inducers and inhibitors. Use of CYP-450 substrates are allowed in the protocol with the exception of CYP-2D6 and CYP-2C8 substrates.
  • Use of any investigational drug (i.e. drugs not approved for any indication) within 30 days prior to study entry.
  • Evidence of active infection or acute illness of any kind within 14 days prior to study entry,including HIV-associated opportunistic infection.
  • Chronic diarrhea defined as \>3 stools/day for more than 4 weeks prior to study entry.
  • Documented history of cardiac conduction abnormalities, cardiac arrhythmias, or cardiomyopathy, any repolarization delay (QTc \>500msec) or a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia).
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Any other medical or psychological condition that might, in the opinion of the site investigator, interfere with participation in the study or put the patients at undue risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

London, SW10 9TH, United Kingdom

Location

Related Publications (1)

  • Moyle G, DeJesus E, Boffito M, Wong RS, Gibney C, Badel K, MacFarland R, Calandra G, Bridger G, Becker S; X4 Antagonist Concept Trial Study Team. Proof of activity with AMD11070, an orally bioavailable inhibitor of CXCR4-tropic HIV type 1. Clin Infect Dis. 2009 Mar 15;48(6):798-805. doi: 10.1086/597097.

    PMID: 19193109RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

mavorixafor

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 7, 2006

Study Start

October 1, 2005

Primary Completion

August 1, 2006

Study Completion

April 1, 2010

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

US(1)GB(1)