Combining a TLR9 agonist with broadly neutralizing antibodies forreservoir reduction and immunological control of HIV infection: Aninvestigator-initiated randomized, placebo-controlled, phase IIa trial(TITAN)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 48

Inclusion Criteria

- Documented HIV-1 infection
- Adults age 18-65 year
- On antiretroviral therapy for a minimum of 18 months
- CD4+ count >500 at screening
- HIV-1 RNA plasma level of < 50 copies/mL by standard assays for at
least 15 months (a single viral load measurement > 50 but < 500
copies/mL during this time period is allowable)
- Viral reservoir sensitivity to 3BNC117 and 10-1074 (analyzed using the
PhenoSense HIV mAb Assay, Monogram Biosciences).
- Able to give informed consent
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 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any significant acute medical illness requiring hospitalization in the
past 4 weeks
- Any evidence of an active AIDS-defining opportunistic infection
- Any condition that, in the Investigator's opinion, will prevent adequate
compliance with study therapy
- The following laboratory values at screening, the values can be
repeated within the screening period, but test results must be available
before baseline (Day 0) and checked for eligibility:
o Hepatic transaminases (AST or ALT) =3 x upper limit of normal
(ULN)
o Serum total bilirubin =3 ULN
o Estimated glomerular filtration rate (eGFR) =50 mL/min (based on
serum creatinine)
o Platelet count =100 x109/L
o Absolute neutrophil count =1x109/L
- Hepatitis B or C infection as indicated by the presence of hepatitis B
surface antigen or hepatitis C virus RNA in blood
- History of:
o Malignancy, excluding non-melanoma skin cancers, or organ
transplantation
- Receipt of strong immunosuppressive or systemic chemotherapeutic
agents within 28 days prior to study entry
- Known resistance to >2 classes of ART
- Known hypersensitivity to the components of lefitolimod, 3BNC117, 10-
1074 or their analogues
- Pre-existing autoimmune or antibody-mediated diseases
- Women who are pregnant or breastfeeding, or with a positive
pregnancy test as determined by a positive urine beta- human chorionic
gonadotropin test during screening or women of child bearing potential
who are unwilling or unable to use an acceptable method of nonestrogen
containing contraception (according to the Danish Medicines
Agency guidelines) to avoid pregnancy during the study
- Males or females who are unwilling or unable to use barrier
contraception during sexual intercourse until plasma HIV-1 RNA is
undetectable using standard assays

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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