A pilot, randomized, open-label, non-active comparator controlled clinical trial to evaluate the effects of letermovir prophylaxis on T-cell immune activation in participants with treated HIV-1 Infectio
- Conditions
- Human immunodeficiency virus 1Infections and InfestationsHIV
- Registration Number
- ISRCTN64393078
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 36
1. Is HIV-1 antibody positive with a plasma HIV-1 RNA =50 copies/mL for greater than 12 months
2. =50 years of age of any gender
3. Females of childbearing potential who agree to avoid pregnancy for the duration of the trial and follow methods of contraception as detailed in section 7.1
4. Has a nadir CD4 of =200 cells/mm3 prior to screening
5. Has been on antiretroviral therapy for = 6 months
6. Has documented CMV IgG seropositivity within one year of trial screening
7. Has an undetectable (=168 international units/mL) CMV Deoxyribonucleic acid (DNA) within 14 days prior to randomisation
8. Laboratory parameters are not clinically significant as determined by the investigator
9. The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial and Future Biomedical Research
1. Has a history of ulcerative colitis or Crohn’s disease or active colitis within 6 months prior to randomisation
2. Has a history of CMV end-organ disease within 6 months prior to randomisation
3. Has significant hypersensitivity or other contraindication to any of the components of the trial drug as described in the SmPC
4. Has a detectable HCV RNA or hepatitis B surface antigen (HBsAg) within 90 days prior to randomisation
5. Has a history of malignancy =5 years prior to signing informed consent
6. Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 90 days after the last dose of trial therapy
7. Has received within 7 days prior to screening any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir (= 3200 mg PO per day or =25 mg/kg IV per day); valaciclovir (=3000 mg PO per day) or famciclovir (=1500 mg PO per day).
8. Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this trial or is anticipated to need them during the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of activated CD8 T cells (CD38+HLADR+) measured in PBMC in response to letermovir at baseline, weeks 4, 8, 12, 16 and 24
- Secondary Outcome Measures
Name Time Method