RAs United as a Novel Anti-HIV strategy (LUNA): a randomized controlled trial.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

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. Transmitted mutations and acquired mutations due to
virological failure associated with resistance of at highest low-level
resistance are allowed.
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.

Exclusion Criteria

1. 1. Previous virological failure, defined as either acquired resistance
mutations (>low level resistance) on cART or HIV-RNA >1000 copies/mL on two
consecutive measurements 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 myeloablative chemotherapy for hematological
malignancies 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, except if their sexual partner(s) use PREP.
12. Patients with active substance abuse or registered allergies to the
investigational medical products.
13. 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in HIV reactivation in the reservoir in vivo at treatment initiation<br /><br>and at the end of treatment measured as the change in cell associated HIV-RNA.<br /><br>The change in reactivation is compared between the treatment arms.</p><br>

Secondary Outcome Measures