NCT00089466

Brief Summary

New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and anti-HIV activity of eight different doses of the HIV entry inhibitor AMD11070 (also known as AMD070) in HIV infected patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

August 5, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 9, 2021

Status Verified

October 1, 2012

Enrollment Period

1.6 years

First QC Date

August 5, 2004

Last Update Submit

November 4, 2021

Conditions

HIV Infections

Keywords

Entry InhibitorsCXCR4 Entry InhibitorsTreatment ExperiencedTreatment Naive

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicities of Grade 3 or greater

    during the 10 days of treatment or the 7 days after stopping treatment

  • Reduction in X4-tropic virus from baseline of 1 log10 relative luciferase units (rlu)

    day 10

Study Arms (8)

A

EXPERIMENTAL

200 mg AMD11070 every 12 hours

Drug: AMD11070

B

EXPERIMENTAL

400 mg AMD11070 every 12 hours

Drug: AMD11070

C

EXPERIMENTAL

600 mg AMD11070 every 12 hours

Drug: AMD11070

D

EXPERIMENTAL

800 mg AMD11070 every 12 hours

Drug: AMD11070

E

EXPERIMENTAL

1000 mg AMD11070 daily

Drug: AMD11070

F

EXPERIMENTAL

1500 mg AMD11070 daily

Drug: AMD11070

G

EXPERIMENTAL

1000 mg AMD11070 every 12 hours

Drug: AMD11070

H

EXPERIMENTAL

2000 mg AMD11070 daily

Drug: AMD11070

Interventions

AMD11070DRUG

AMD11070 taken daily. Dosage dependent on arm.

ABCDEFGH

Eligibility Criteria

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

You may qualify if:

  • HIV-1 infected
  • Have X4- or dual/mixed-tropic virus confirmed no more than 56 days prior to study entry
  • HIV-1 viral load of 5,000 copies/ml or more within 60 days prior to study entry
  • If female, willing to discontinue hormonal contraception 1 week prior to study entry
  • Willing to use acceptable forms of contraception

You may not qualify if:

  • Antiretroviral treatment within 14 days prior to study entry
  • Other prescription medications, herbal supplements, or aspirin within 7 days prior to study entry. Patients taking medication for prophylaxis for Pneumocystis carinii pneumonia (PCP) are not excluded. Patients taking medications approved by protocol officials are not excluded, provided they have been on a stable dose for at least 14 days prior to study entry.
  • Nonsteroidal anti-inflammatory drugs (NSAIDS), over the counter medications, or other supplements (including multivitamins) within 1 day prior to study entry
  • Heavy exercise within 24 hours before study entry evaluations are done
  • Immunizations within 30 days prior to study entry
  • Radiation therapy, cytotoxic chemotherapeutic agents, or immunomodulatory agents within 30 days prior to study entry
  • Current use of some CYP substrates, inhibitors, or inducers. Use of CYP450 substrates is allowed, except for CYP2D6 and CYP2C8 substrates.
  • Current use of P-gp inducers or inhibitors
  • Allergy or sensitivity to study drug or its formulations
  • Active infection or acute illness within 14 days prior to study entry, including HIV-associated opportunistic infections
  • History of heart abnormalities. Patients with any repolarization delay (QTc interval of greater than 500 msec) or a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia) are also excluded.
  • Drug or alcohol abuse or dependence or other medical or psychological condition that, in the opinion of the investigator, would interfere with the study or put participants at undue risk
  • Chronic diarrhea, defined as having more than 3 stools/day for more than 4 weeks prior to study entry
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alabama Therapeutics CRS

Birmingham, Alabama, 35924-2050, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, 30308, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202-5250, United States

Location

Related Publications (5)

  • De Clercq E. Emerging anti-HIV drugs. Expert Opin Emerg Drugs. 2005 May;10(2):241-73. doi: 10.1517/14728214.10.2.241.

    PMID: 15934866BACKGROUND

  • Moore JP, Kitchen SG, Pugach P, Zack JA. The CCR5 and CXCR4 coreceptors--central to understanding the transmission and pathogenesis of human immunodeficiency virus type 1 infection. AIDS Res Hum Retroviruses. 2004 Jan;20(1):111-26. doi: 10.1089/088922204322749567.

    PMID: 15000703BACKGROUND

  • Reeves JD, Piefer AJ. Emerging drug targets for antiretroviral therapy. Drugs. 2005;65(13):1747-66. doi: 10.2165/00003495-200565130-00002.

    PMID: 16114975BACKGROUND

  • Ruibal-Ares BH, Belmonte L, Bare PC, Parodi CM, Massud I, de Bracco MM. HIV-1 infection and chemokine receptor modulation. Curr HIV Res. 2004 Jan;2(1):39-50. doi: 10.2174/1570162043484997.

    PMID: 15053339BACKGROUND

  • Shaheen F, Collman RG. Co-receptor antagonists as HIV-1 entry inhibitors. Curr Opin Infect Dis. 2004 Feb;17(1):7-16. doi: 10.1097/00001432-200402000-00003.

    PMID: 15090884BACKGROUND

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

  • Michael S. Saag, MD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2004

First Posted

August 6, 2004

Study Start

November 1, 2004

Primary Completion

June 1, 2006

Study Completion

January 1, 2009

Last Updated

November 9, 2021

Record last verified: 2012-10

Locations

US(3)