Recruitment

Recruitment Status
Completed

Inclusion Criteria

Female subjects of reproductive potential must have a negative spot urine pregnancy test result (with a sensitivity of at least 50 mIU/mL) performed at entry, prior to starting initial study treatment.
Hemoglobin greater or equal than 10.0 g/dL
AST (SGOT), ALT (SGPT), and alkaline phosphatase less or equal than 2 x ULN
...
Female subjects of reproductive potential must have a negative spot urine pregnancy test result (with a sensitivity of at least 50 mIU/mL) performed at entry, prior to starting initial study treatment.
Hemoglobin greater or equal than 10.0 g/dL
AST (SGOT), ALT (SGPT), and alkaline phosphatase less or equal than 2 x ULN
Condoms (male or female) with or without a spermicidal agent
Men and women greater or equal than 18 years of age.
Willing to return for a follow-up visit on day 58.
Creatinine less or equal than 2 x ULN (fasting)
Albumin greater or equal than 3 g/dL
Antiretroviral treatment with a regimen that includes either atazanavir 300 mg daily with ritonavir 100 mg daily or darunavir/ritonavir on a combination of 800/100 mg daily for at least 6 months prior to enrollment.
Subjects taking any precautionary concomitant medications must be on stable doses for >8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study.
Platelet count greater or equal than 100,000/mm3
Ability and willingness of subject or legal guardian/representative to give written informed consent.
Total bilirubin less or equal than 2.5 x ULN
Absolute neutrophil count (ANC) greater or equal than 750/mm3
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
IUD
Plasma HIV-1 RNA below the limit of quantification of an ultrasensitive assay as measured by any standard assay (the Roche Amplicor, the UltraSensitive HIV-1 Monitor assay (Roche Molecular Systems), or Version 3 bDNA assay or other) for at least 6 months prior to enrollment by any laboratory that is CLIA-certified (or its equivalent) for the assay.
Karnofsky performance score greater or equal than 80 within 30 days prior to study entry (Appendix I).
CD4+ cell count ≥ 350/mm3 for at least 6 months prior to enrollment and performed at any CLIA-certified laboratory.
Diaphragm or cervical cap with spermicide

Exclusion Criteria

Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry. However, if the experimental agent has a short half life, as determined by the Principal Investigator, the required wash out period can be reduced to 30 days.
History of allergy to aprepitant or its formulations.
History of chronic active hepatitis B or C infection or severe hepatic dysfunction (Child-Pugh score > 9) regardless of etiology
...
Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry. However, if the experimental agent has a short half life, as determined by the Principal Investigator, the required wash out period can be reduced to 30 days.
History of allergy to aprepitant or its formulations.
History of chronic active hepatitis B or C infection or severe hepatic dysfunction (Child-Pugh score > 9) regardless of etiology
Use of inducers of metabolism by the cytochrome P450 3A4 (i.e.: Rifampin, Carbamazepine, Phenytoin) with the exception of the protease inhibitors considered in this trial.
Diabetes requiring treatment with oral hypoglycemics or insulin therapy.
Pregnancy within 90 days prior to study entry.
History of severe psychiatric comorbidities, such as depression, schizophrenia, mania, psychosis
Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry.
Breast-feeding.
Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
Use of systemic cytotoxic chemotherapy within 90 days prior to study entry.
Use of inhibitors of metabolism by the cytochrome P450 3A4 with the exception of ritonavir, atazanavir and darunavir (i.e. Diltiazem, Ketoconazole, Clarithromycin, Nelfinavir, Itraconazole, Nefazodone, Troleandomycin)
Any vaccination within 30 days prior to study entry.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Weight < 40 kg or 88 lbs. within 90 days prior to study entry.

Summary

Conditions
HIV Infection
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is an open-label, single arm, phase I study to determine the safety, PK characteristics and anti-inflammatory effects of the NK-R1 coadministered with ritonavir-containing antiretroviral therapy in individuals with well-controlled viral replication. Our hypothesis is that Aprepitant will be saf...

This is an open-label, single arm, phase I study to determine the safety, PK characteristics and anti-inflammatory effects of the NK-R1 coadministered with ritonavir-containing antiretroviral therapy in individuals with well-controlled viral replication. Our hypothesis is that Aprepitant will be safe, well tolerated, and will have anti-inflammatory properties when administered concomitantly with the protease inhibitor ritonavir. The study will recruit 12 participants receiving either darunavir/ritonavir or atazanavir/ritonavir

Inclusion Criteria

Female subjects of reproductive potential must have a negative spot urine pregnancy test result (with a sensitivity of at least 50 mIU/mL) performed at entry, prior to starting initial study treatment.
Hemoglobin greater or equal than 10.0 g/dL
AST (SGOT), ALT (SGPT), and alkaline phosphatase less or equal than 2 x ULN
...
Female subjects of reproductive potential must have a negative spot urine pregnancy test result (with a sensitivity of at least 50 mIU/mL) performed at entry, prior to starting initial study treatment.
Hemoglobin greater or equal than 10.0 g/dL
AST (SGOT), ALT (SGPT), and alkaline phosphatase less or equal than 2 x ULN
Condoms (male or female) with or without a spermicidal agent
Men and women greater or equal than 18 years of age.
Willing to return for a follow-up visit on day 58.
Creatinine less or equal than 2 x ULN (fasting)
Albumin greater or equal than 3 g/dL
Antiretroviral treatment with a regimen that includes either atazanavir 300 mg daily with ritonavir 100 mg daily or darunavir/ritonavir on a combination of 800/100 mg daily for at least 6 months prior to enrollment.
Subjects taking any precautionary concomitant medications must be on stable doses for >8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study.
Platelet count greater or equal than 100,000/mm3
Ability and willingness of subject or legal guardian/representative to give written informed consent.
Total bilirubin less or equal than 2.5 x ULN
Absolute neutrophil count (ANC) greater or equal than 750/mm3
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
IUD
Plasma HIV-1 RNA below the limit of quantification of an ultrasensitive assay as measured by any standard assay (the Roche Amplicor, the UltraSensitive HIV-1 Monitor assay (Roche Molecular Systems), or Version 3 bDNA assay or other) for at least 6 months prior to enrollment by any laboratory that is CLIA-certified (or its equivalent) for the assay.
Karnofsky performance score greater or equal than 80 within 30 days prior to study entry (Appendix I).
CD4+ cell count ≥ 350/mm3 for at least 6 months prior to enrollment and performed at any CLIA-certified laboratory.
Diaphragm or cervical cap with spermicide

Exclusion Criteria

Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry. However, if the experimental agent has a short half life, as determined by the Principal Investigator, the required wash out period can be reduced to 30 days.
History of allergy to aprepitant or its formulations.
History of chronic active hepatitis B or C infection or severe hepatic dysfunction (Child-Pugh score > 9) regardless of etiology
...
Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry. However, if the experimental agent has a short half life, as determined by the Principal Investigator, the required wash out period can be reduced to 30 days.
History of allergy to aprepitant or its formulations.
History of chronic active hepatitis B or C infection or severe hepatic dysfunction (Child-Pugh score > 9) regardless of etiology
Use of inducers of metabolism by the cytochrome P450 3A4 (i.e.: Rifampin, Carbamazepine, Phenytoin) with the exception of the protease inhibitors considered in this trial.
Diabetes requiring treatment with oral hypoglycemics or insulin therapy.
Pregnancy within 90 days prior to study entry.
History of severe psychiatric comorbidities, such as depression, schizophrenia, mania, psychosis
Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry.
Breast-feeding.
Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
Use of systemic cytotoxic chemotherapy within 90 days prior to study entry.
Use of inhibitors of metabolism by the cytochrome P450 3A4 with the exception of ritonavir, atazanavir and darunavir (i.e. Diltiazem, Ketoconazole, Clarithromycin, Nelfinavir, Itraconazole, Nefazodone, Troleandomycin)
Any vaccination within 30 days prior to study entry.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Weight < 40 kg or 88 lbs. within 90 days prior to study entry.

Locations

Philadelphia, Pennsylvania, 19104
Philadelphia, Pennsylvania, 19104

Tracking Information

NCT #
NCT02154360
Collaborators
Not Provided
Investigators
  • Principal Investigator: Pablo Tebas, MD University of Pennsylvania
  • Pablo Tebas, MD University of Pennsylvania