Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02946047
Other study ID # 16-001938
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 20, 2017
Est. completion date August 19, 2019

Study information

Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the trial is to determine the safety and tolerability of ixazomib in HIV infected patients on antiretroviral therapy. The secondary purpose is to determine the effect of ixazomib on the size of the HIV reservoir.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date August 19, 2019
Est. primary completion date August 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The following laboratory values obtained <=14 days prior to registration. - ANC = LLN (lower limit of normal) and =ULN (upper limit of normal), Hgb = LLN and =ULN, PLT = LLN and =ULN - Total bilirubin =ULN and the direct bilirubin must be = ULN; AST <1.5 x ULN and ALT <1.5 x ULN - Creatinine <2.0 x ULN and an estimated creatinine clearance > 60 ml/min - HIV infection with suppressed viral replication on at least 3 active drug ART for at least 6 months - Suppressed viral replication is defined by plasma HIV viral load <20copies/mL. - Patient must have HIV viral load <20 copies/ml on two occasions at least 3 months apart. - In the opinion of the treating physician, patients must have available other regimens likely to suppress HIV should their current regimen fail. - Male or female patients age >=18 years - A plasma HIV RNA viral load demonstrating a measure of <20 copies/mL within 30 days prior to study initiation. - CD4 count >500 cells/mm3 within 30 days prior to study enrollment - Females must have a negative pregnancy test prior to receiving the 1st dose of ixazomib and be postmenopausal for at least 1 year before the screen visit, or surgically sterile, - Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: - Agree to practice effective barrier contraception AND a second method of contraception for female partners of childbearing potential during the entire study treatment period and through 90 days after the last dose of ixazomib, - OR - Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) - AND - Agree to forego sperm donation for the same period as above. Exclusion Criteria: - The following laboratory values obtained <=14 days prior to registration. - ANC < LLN and >ULN, Hgb < LLN and >ULN, PLT < LLN and >ULN - Total bilirubin >ULN or the direct bilirubin is > ULN; AST >1.5 x ULN or AST >1.5 x ULN - Creatinine >=2.0 x ULN or an estimated creatinine clearance <=60mL/min - Diagnosed and treated for a malignancy within 5 years before randomization, or previously diagnosed with a malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection - Any infection except HIV (excluding benign conditions that is unlikely to be affected or modulated by treatment with ixazomib, e.g. stye or furuncle), or treatment with anti-infective agents within 14 days of enrollment. - Pregnant women - Women of childbearing potential and Nursing women - Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking the drug and for 90 days after stopping ixazomib. - Any history of peripheral neuropathy, or peripheral neuropathy detected during the screening period. - Major surgery within 14 days before study registration - Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin,carbamazepine, phenytoin, phenobarbital), or use of St. John's wort. - Evidence of current uncontrolled cardiovascular conditions, including serious cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months. - QTc > 450 milliseconds (msec) for men and >470 milliseconds for women (83) on a 12 lead ECG obtained during the Screening period. - Known hepatitis B DNA positive status and/or HBsAg positive and/or HBeAg positive, or active hepatitis C replication (HCV RNA positive) or currently on hepatitis C treatment. - Known history of cirrhosis or active liver inflammation, including "fatty liver" or non-alcohol steatohepatitis (NASH). - Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. - Known allergy to any of the study medications, their analogues or excipients in the various formulations. - Any other recent or concurrent medical condition that, in the Investigator's opinion, would impose any risk to the patient - Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing. - Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.

Study Design


Related Conditions & MeSH terms

  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Human Immunodeficiency Virus (HIV)

Intervention

Drug:
Ixazomib 1 MG
1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
Ixazomib 2 MG
2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
Ixazomib 3 MG
3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
Ixazomib 4 MG
4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events Number of treatment-emergent adverse events experienced by subjects as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 7 months
Secondary Cell Associated HIV DNA in CD4 T Cell Subsets HIV copies per million CD4 T cells 24 weeks
Secondary Culturable HIV by Quantitative Viral Outgrowth Assay Infectious units per million CD4 T cells 24 weeks
Secondary Absolute CD4 T Cell Count Cells per microliter 24 weeks
Secondary Absolute CD8 T Cell Count Cells per microliter 24 weeks
Secondary CD4/CD8 Ratio CD4/CD8 T cell count ratio 24 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Completed NCT02234492 - The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients Phase 4
Completed NCT01685372 - Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults Phase 2
Completed NCT02027441 - Enhanced Prevention in Couples: Feasibility Study #2 N/A
Completed NCT02165202 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis Phase 2
Completed NCT02572401 - Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men N/A
Terminated NCT01448486 - A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV Phase 4
Completed NCT01449006 - A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac) Phase 4
Completed NCT01615601 - An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients Phase 4
Completed NCT04122404 - POC Strategies to Improve TB Care in Advanced HIV Disease N/A
Completed NCT03290755 - Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
Completed NCT02974998 - Cape Town Young Women's Health CoOp N/A
Completed NCT01516970 - Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) Phase 3
Completed NCT01997346 - Multi-level Determinants of Starting ART Late: Aim 2 N/A
Active, not recruiting NCT01875952 - Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL) Phase 4
Completed NCT01199939 - A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients Phase 2
Completed NCT03783130 - Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults Phase 1
Active, not recruiting NCT05657106 - Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk N/A
Not yet recruiting NCT05727033 - Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections N/A
Completed NCT01053741 - Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission N/A

External Links