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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company

Criteria

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 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.

Exclusion Criteria:

• 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.