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New treatment option for HIV-1
Official title Inhibiting the Anti-apoptotic Factor, BCL-2, at the Time of ART Initiation to Promote Apoptosis of HIV-infected Cells and Restrict the Seeding of the HIV Reservoir (The INITIATE Study)
ClinicalTrials.gov ID: NCT07481175
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as an once-daily, being studied as a potential treatment for hiv-1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Combination therapy with antiretroviral medication (ART) has proven effective in keeping HIV suppressed and restoring the immune system, but it cannot cure the infection. Therefore, lifelong treatment is necessary.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Documented HIV-1 infection
- Age 18-70 years (both included) at screening
- CD4+ T cell count \>300/µL at screening
- ART naïve at screening
- Able to give informed consent
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study.
- Current or previous use of a BCL-2 antagonist or other pro-apoptotic agent used as cancer therapy
- Evidence of or strong suspicion that HIV infection was acquired during active PrEP use
- Any concomitant disease where venetoclax treatment is indicated
- Current use of any moderate or strong CYP3A4 inhibitors (such as ketoconazole, voriconazole, posaconazole, itraconazole, ritonavir, cobicistat and...
- Current use of any HIV protease inhibitor (due to CYP3A4 inhibition)
See the full eligibility criteria
- Documented HIV-1 infection
- Age 18-70 years (both included) at screening
- CD4+ T cell count \>300/µL at screening
- ART naïve at screening
- Able to give informed consent
- Ability and willingness to provide informed consent and to continue ART throughout the study
- All participants must agree to use condoms during all sexual intercourse in situations where HIV transmission may still occur, i.e. until fully suppressed on ART (plasma HIV-1 RNA \<50 copies/mL)
- All participants must agree not to participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study
- An individual who meets any of the following criteria will be excluded from participation in this study.
- Current or previous use of a BCL-2 antagonist or other pro-apoptotic agent used as cancer therapy
- Evidence of or strong suspicion that HIV infection was acquired during active PrEP use
- Any concomitant disease where venetoclax treatment is indicated
- Current use of any moderate or strong CYP3A4 inhibitors (such as ketoconazole, voriconazole, posaconazole, itraconazole, ritonavir, cobicistat and clarithromycin)
- Current use of any HIV protease inhibitor (due to CYP3A4 inhibition)
- Current use of any strong inhibitor of the P-gp drug efflux pump (this includes cobicistat, ritonavir, azithromycin and clarithromycin)
- Current use of P-gp substrates with narrow therapeutic index (such as such as digoxin, tacrolimus, cyclosporine, sirolimus, dabigatran, colchicine, loperamide)
- Current use of strong or moderate CYP3A4 inducers (such as carbamazepine, phenytoin, rifampicin, St. John's wort, bosentan, efavirenz and etravirine); intermittent use of moderate CYP3A4 inducers such as modafinil and...
- Receipt of immunomodulating agents (excluding immunisation) or systemic chemotherapeutic agents within 28 days prior to study entry
- Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
- Known hypersensitivity to the components of venetoclax or its analogues
- Any evidence of an active AIDS-defining opportunistic infection
- Individuals who intend to modify their ART regimen within the study period
- Current or recent gastrointestinal disease or gastrointestinal surgery that may impact the absorption of the investigational drug
- Active alcohol or substance use that, in the Investigator's opinion, will prevent adequate compliance with study therapy or procedures
- Unable or unwilling to adhere to protocol procedures
- History of malignancy or transplantation, excluding adequately treated basal cell carcinoma
- Co-infection with hepatitis B defined as HBsAg-positive or Hepatitis C defined as HCV-RNA positive (Individuals with prior hepatitis B or C infection that is now cleared are eligible for enrolment)
- For individuals with isolated anti-HBcAb (cleared hepatitis B), the chosen ART regimen must include TDF or TAF
- Impaired liver function with AST or ALT \>3 times upper limit of normal
- Severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Impaired renal function with estimated creatinine clearance (eGFR) \<50 mL/min
- Significant cardiac dysfunction
- Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria
- The following laboratory values at screening (lab tests may be repeated, as clinically indicated, to obtain acceptable values before failure at screening is concluded but supportive therapies are not to be administered...
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Badalona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Badalona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.