A study on HIV eradication by using medicines together.

Phase 1

• Conditions: Adults with human immunodeficiency virus type-1 infection on antiretroviral treatment with adequate viral suppression and good cellular immunity.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-002837-48-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-24
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1.HIV-1 infected patients =18 years.
2.WHO performance status 0 or 1.
3.Confirmed HIV-1 infection by 4th generation ELISA, Western Blot or PCR.
4.Wild type HIV infection or polymorphisms associated with at highest low-level resistance to any class of ART according to Stanford HIV drug resistance database.
5.On cART.
6.Current plasma HIV-RNA <50 copies/mL for at least 365 days and measured on at least 2 occasions of which at least 1 must be obtained within 365 and 90 days prior to study entry.
7.Current CD4 count at study entry of =200 cells/mm3.
8.Pre-cART HIV-RNA =10.000 copies/mL.
9. Pre-cART HIV-RNA =10.000 copies/mL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous virological failure, defined as either acquired resistance mutations on cART or HIV-RNA >1000 copies/mL twice during cART.
2.Uncontrolled hepatitis B or C co-infection.
3.Prior exposure to any HDACi, BAFi or other known LRA.
4.Prior exposure to cytotoxic chemotherapy during cART.
5.Concurrent exposure to strong interacting medication on glucuronidation.
6.Exposure within 90 days prior to study entry to immunomodulators, cytokines, systemic antifungals, dexamethasone, vitamin K antagonists, anti-epileptics, antipsychotica, carbapenems, mefloquine, colestyramine, Any documented opportunistic infection related to HIV in the last 90 days.
7.Inadequate blood counts, renal and hepatic function tests
a.Haemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females), leucocytes <2.5 x109/L, absolute neutrophil count <1000 cells/mm3, thrombocytes <100 x109/L, international standardized ratio >1.6, activated partial thromboplastin time >40 seconds.
b.Estimated glomerular filtration rate <50 mL/min (CKD-EPI),
c.ALAT or total bilirubin >2.5x upper limit of normal.
d.All laboratory values must be obtained within 42 days prior to the baseline visit.
8.Megaloblastic anemia due to folate deficiency.
9.Pancreatitis in last 6 months, or chronic pancreatitis.
10.Active malignancy during the past year with the exception of basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi Sarcoma treated with cART alone, or other indolent malignancies.
11.Females in the reproductive age cannot participate. Males cannot participate if they refuse to abstain from sex or condom use in serodiscordant sexual contact during the study.
12.Patients with active substance abuse or registered allergies to the investigational medical products.
Last, any other condition (familial, psychological, sociological, geographical) which in the investigator’s opinion poses an unacceptable risk or would hamper compliance with the study protocol and follow up schedule, will prohibit participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified