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HIV InfectionsPhase 1NCT00361101

A Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus

A Phase 1 study testing AMD11070 in people with HIV Infections and X4 Tropic Virus, run by Genzyme, a Sanofi Company at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, X4 Tropic Virus
What is being tested?
AMD11070
Type of treatment
Pill or oral medicine
How many people
10 participants
Where
2 sitesin 2 countries
Study dates
Oct 2005to Apr 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Study site

    Orlando, Florida, 32803

Other trials in United States

United Kingdom1 site

  • Study site

    London, SW10 9TH

Other trials in United Kingdom

About this study

Official title: Multicenter, Dose-finding Safety and Activity Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus.

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

Read the detailed description

AMD11070 is a new chemical entity that inhibits HIV-1 entry by binding specifically and reversibly to CXCR4, a coreceptor required by T-tropic virus for membrane fusion and entry into cells. The purpose of this study is to evaluate the safety and relative antiretroviral activity of AMD11070 in HIV-infected individuals who have demonstrated X4 -tropic virus in their plasma. With the ongoing development of other fusion and entry inhibitors and the need for alternative treatment options in patients (especially those with multidrug resistant virus), the demonstration of activity and safety of AMD11070 represents a potentially important advance in antiretroviral therapeutics. This will be the first study that determines the therapeutic potential of anti-CXCR4 compounds in HIV-infected patients.

Note: Study was previously suspended due to non-clinical reports of hepatotoxicity and histologic findings. Study has been completed.

Being tested
AMD11070
Keywords
HIV, X4 tropic virus
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMD11070Drug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and antiviral activity of AMD11070 administered in HIV-infected patients who harbor-X4-tropic virus.

    Measured: 10 days

  2. 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.

    Measured: 10 days

Secondary outcomes (5)

  1. the relationship between standard pharmacokinetic (PK) measures, viral response, and a shift in T-cell receptor tropism.

    Measured: 10 days

  2. the relationship of coreceptor tropism phenotype to CD4+ count, viral load, and drug resistance in the screening patient population.

    Measured: 10 days

  3. 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.

    Measured: 10 days

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

    Measured: 10 days

  5. change from baseline in CD34+ cells

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionAug 2006
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00361101
Sponsor's protocol ID
AMD11070-1001
Status last verified
Feb 2014
First submitted
3 Aug 2006
Last updated
11 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19193109

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMD11070 in people with HIV Infections and X4 Tropic Virus, run by Genzyme, a Sanofi Company at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and antiviral activity of AMD11070 administered in HIV-infected patients who harbor-X4-tropic virus. (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00361101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.

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