An observational study in HIV Infection and Liver Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Among 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) — 10 open to participants now, 15 under way, 1 of them phase 3. HIV Infections · National Institute of Allergy and Infectious Diseases (NIAID).
Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 92nd largest by planned enrollment of the 136 observational ones that give a count, is one of 3 that started in 2026, is one of 142 observational ones, reaches primary completion later than 12 of the 12 other live ones, and was the 1,034th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
Browse HIV Infections studies →10 of the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) are open now, in 12 countries. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States, Peru
Ages 18–60 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–55 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States, Brazil, Peru
Ages 18–70
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States, Argentina, Brazil and 10 more countries
Ages up to 48 hrs
By country, each count listing its studies:
Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,034 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 411 · Phase 2 276 · Phase 3 101 · Phase 4 10
First in 1984; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is below the median of 200 across 781 observational studies indexed under HIV Infections.
Median enrollment 59 across the 883 interventional studies, 174 across the 136 observational. Of the 962 that completed or were terminated, 130 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
5 of the studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06796686National Institute of Allergy and Infectious Diseases (NIAID)Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health | 2027-01-15 |
| NCT06557785National Institute of Allergy and Infectious Diseases (NIAID)A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV | 2027-03-09 |
| NCT07342491National Institute of Allergy and Infectious Diseases (NIAID)Dasatinib for HIV-1 Reservoir Reduction | 2027-04-09 |
| NCT06508749National Institute of Allergy and Infectious Diseases (NIAID)The Tatelo Plus Study | 2027-09-03 |
| NCT06665646National Institute of Allergy and Infectious Diseases (NIAID)Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706 | 2027-11-30 |
Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, multicenter clinical study. The objective is to determine whether a liver transplant from a deceased donor with HIV is associated with an increased risk of opportunistic infection and cancer. Adults with Human Immunodeficiency Virus (HIV) in need of a liver or simultaneous liver-kidney (SLK) transplant who meet study-specified criteria will be offered enrollment in the study. The analytic plan includes an observational cohort of liver and SLK transplant recipients from prior HOPE in Action studies.
This is a prospective, multicenter observational study of liver transplantation from deceased donors with Human Immunodeficiency Virus (HIV) to recipients with HIV. The primary objective is to determine whether liver transplantation (LT) from donors with HIV to recipients with HIV (HIV D+/R+) is associated with an increased risk of opportunistic infections or cancer compared with LT from donors without HIV to recipients with HIV (HIV D-/R+).
Adults with HIV who require a liver transplant or simultaneous liver-kidney (SLK) transplant and meet study eligibility criteria will be enrolled. Participants who receive a liver or SLK transplant from a donor with HIV will be assigned to the HIV D+/R+ cohort. Participants who receive a liver or SLK transplant from a donor without HIV, including donors with suspected false-positive HIV screening tests that are subsequently confirmed HIV negative, will be assigned to the HIV D-/R+ cohort. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant.
To improve precision in estimating the association between donor HIV status and the risk of opportunistic infection or cancer, analyses will incorporate observational cohorts from prior HOPE in Action liver transplantation studies, including the HOPE Liver Pilot Study, HOPE Liver U01 (RTB-009), and the HOPE Liver Long-Term Follow-Up (LLTF) Study, where appropriate. In addition to clinical outcomes, biospecimens will be collected to investigate virologic and immunologic mechanisms that may contribute to infection and cancer risk following transplantation from donors with HIV.
In order to have maximum power to precisely estimate the risk of opportunistic infection or cancer attributable to donor HIV status, this trial population (n=80) will be combined with prior HOPE in Action cohorts: HOPE Pilot; HOPE Liver U01 RTB-009, HOPE Liver Long Term Follow Up (LLTF) study.
The study will use data from HOPE Pilot and HOPE Liver U01 RTB-009 through end of follow up and participants will also be approached for enrollment to continue long-term follow-up for up to 10 years in the HOPE LLTF study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Recipient Inclusion Criteria
Deceased Donor Criteria
Exclusion Criteria:
Recipient
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who receive a liver or SLK from a donor without HIV (D-) will be in this arm. Participants who accept an HIV suspected false positive (FP) organ will be part of the D-/R+ arm once confirmatory testing confirms the negative HIV status of the donor. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant
Prospective cohort of transplant recipients who receive a liver or SLK from a donor with HIV (D+) will be in the HIV D+/R+ arm. Participants will be followed for a minimum of 6 months and up to 4 years post-transplant
Incidence of a composite event of opportunistic infection or cancer in Human Immunodeficiency Virus (HIV)-infected donor (HIV D+)/recipient (R+) compared with HIV-uninfected donor (HIV D-)/recipient (R+) liver transplant recipients
Time frame: From transplant through 4 years post-transplant
Overall survival measured as time from transplantation to death from any cause
Time frame: From transplant through 4 years post-transplant
Graft survival measured as time from transplantation to graft failure
Graft failure is defined as any of the following events: re-transplantation; death; allograft nephrectomy; initiation of post-donation chronic dialysis (SLK only).
Time frame: From transplant through 4 years post-transplant
Incidence of bacterial infections post-transplant
Time frame: From transplant through 4 years post-transplant
Incidence of post-transplant cancer
As determined by local pathology
Time frame: From transplant through 4 years post-transplant
Type of post-transplant cancer
As determined by local pathology
Time frame: From transplant through 4 years post-transplant
Serious adverse events post-transplant
Time frame: From transplant through 4 years post-transplant
Incidence of rejection events post-transplant
Time frame: From transplant through 4 years post-transplant
Graft function over time as assessed by Fibrosis-4 (FIB-4) Index
Graft function will be assessed over time using the Fibrosis-4 (FIB-4) Index. FIB-4 is calculated using age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count. Higher FIB-4 values are associated with a greater likelihood of liver fibrosis.
Time frame: From transplant through 4 years post-transplant
Graft function over time as assessed by AST to Platelet Ratio Index (APRI)
Graft function will be assessed over time using the Aspartate Aminotransferase (AST) to Platelet Ratio Index (APRI). APRI is calculated using AST level, the upper limit of normal for AST, and platelet count. Higher APRI values are associated with a greater likelihood of liver fibrosis.
Time frame: From transplant through 4 years post-transplant
Incidence of Human Immunodeficiency Virus (HIV)-breakthrough post-transplant
Time frame: From transplant through 4 years post-transplant
Incidence of Human Immunodeficiency Virus (HIV) persistent virologic failure post-transplant
Time frame: From transplant through 4 years post-transplant
Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant
Time frame: From transplant through 4 years post-transplant
Incidence of surgical transplant complications
Time frame: During the first year post-transplant
Incidence of vascular transplant complications
Time frame: During the first year post-transplant
Number of Participants with Positive Kaposi Sarcoma Herpesvirus (KSHV) serology
KSHV serostatus will be assessed using serologic testing for antibodies to KSHV. Participants will be classified as KSHV seropositive or seronegative based on the specified laboratory assay.
Time frame: From transplant through 4 years post-transplant
Kaposi Sarcoma Herpesvirus (KSHV) Polymerase Chain Reaction (PCR) over time
Time frame: From transplant through 4 years post-transplant
Incidence of fungal infections post-transplant
Time frame: From transplant through 4 years post-transplant
Incidence of viral infections post-transplant
Time frame: From transplant through 4 years post-transplant
Incidence of other opportunistic infections post-transplant
Time frame: From transplant through 4 years post-transplant
Plan to share: No
Start is estimated for Oct 2026; primary completion for Aug 2030, 46 months later.
Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 46 months is above that.
Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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National Institute of Allergy and Infectious Diseases (NIAID) →