57 Results
U.S. Clinical Trial Evaluating Antiviral for Monkeypox Begins
September 9, 2022
A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States. Study investigators aim to enroll more than 500 people from clinical research sites nationwide. Interested volunteers can visit the ACTG website (clinical trial A5418) for more information. The NIAID-funded Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) is leading the study, which may later expand to international sites. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at NIH is supporting several sites, including through the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).
NIH Statement on HIV Vaccine Awareness Day 2023
May 18, 2023
Today marks the 26th observance of HIV Vaccine Awareness Day. The National Institutes of Health applauds the efforts of the collaborative global community of scientists, advocates, study participants, study staff, and funders enabling unprecedented levels of innovation and adaptation in the pursuit of a highly effective HIV vaccine.
Monkeypox Treatment Trial Begins in the Democratic Republic of the Congo
October 12, 2022
A clinical trial to evaluate the antiviral drug tecovirimat, also known as TPOXX, in adults and children with monkeypox has begun in the Democratic Republic of the Congo (DRC). The trial will evaluate the drug’s safety and its ability to mitigate monkeypox symptoms and prevent serious outcomes, including death. NIAID and the DRC’s National Institute for Biomedical Research (INRB) are co-leading the trial as part of the government-to-government PALM partnership. Collaborating institutions include the U.S. Centers for Disease Control and Prevention (CDC), the Institute of Tropical Medicine Antwerp, the aid organization Alliance for International Medical Action (ALIMA) and the World Health Organization (WHO).
Statement—Janssen Investigational COVID-19 Vaccine—Interim Analysis
January 29, 2021
NIH reports that an investigational COVID-19 vaccine by Janssen Pharmaceuticals appears to be safe and effective at preventing COVID-19 in adults.
World TB Day 2022—Invest to End TB. Save Lives
March 24, 2022
Today marks the 140th anniversary of the announcement by Dr. Robert Koch that tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis. World TB Day is a reminder that this ancient disease remains a relentless killer. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, affirms its commitment to the 2022 World TB Day theme, Invest to End TB. Save Lives, by supporting and conducting wide-ranging research aimed at reducing the health and economic impacts of TB.
Early HIV diagnosis and treatment important for better long-term health outcomes
October 21, 2022
Starting antiretroviral treatment (ART) early in the course of HIV infection when the immune system is stronger results in better long-term health outcomes compared with delaying ART, according to findings presented today at the IDWeek Conference in Washington, D.C.
HIV Vaccine Candidate Does Not Sufficiently Protect Women Against HIV Infection
August 31, 2021
An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data. The Phase 2b proof-of-concept study, which began in November 2017, enrolled 2,637 women ages 18 to 35 years from five countries.
NIH Awards More than $20 Million to International HIV Database Centers
July 22, 2021
The National Institutes of Health has renewed grants to seven regional centers that compose the International epidemiology Databases to Evaluate AIDS (IeDEA), awarding $20.8 million in first-year funding. The 15-year-old IeDEA program efficiently advances knowledge about HIV by pooling and analyzing de-identified health data from more than two million people with HIV on five continents to answer research questions that individual studies cannot address. The grants are expected to last five years and to total an estimated $100 million.
Three-dose hepatitis B vaccine regimen protects people with HIV
October 20, 2022
A three-dose course of the hepatitis B vaccine HEPLISAV-B fully protected adults living with HIV who had never been vaccinated against or infected with the hepatitis B virus (HBV), according to study findings presented today at the IDWeek conference in Washington, D.C. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsors the ongoing Phase 3 ACTG A5379 clinical study.
NIH Trial of Rectal Microbicide for HIV Prevention Begins in the United States
October 31, 2024
A clinical trial has launched to examine the safety and acceptability of a novel rectal HIV microbicide douche containing the antiretroviral drug tenofovir. While HIV incidence is slowly decreasing in the United States, 67% of U.S. HIV diagnoses from 2018-2022 were among gay, bisexual, and other men who have sex with men, pointing to the need for expanded HIV prevention options. The mid-stage study is sponsored by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and implemented through the NIH-funded HIV Prevention Trials Network.
Kidney Transplantation Between Donors and Recipients with HIV Is Safe
October 16, 2024
Kidney transplantation from deceased donors with HIV to recipients with HIV was safe and comparable to kidney transplantation from donors without HIV.
An Isolated Viral Load Test May Generate False Positive Results for People Using Long-Acting PrEP
July 23, 2024
A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive.
Long-Acting Injectable Cabotegravir for HIV Prevention Is Safe in Pregnancy
July 23, 2024
Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
Exploratory Analysis Associates HIV Drug Abacavir with Elevated Cardiovascular Disease Risk in Large Global Trial
July 23, 2024
Current or previous use of the antiretroviral drug (ARV) abacavir was associated with an elevated risk of major adverse cardiovascular events (MACE) in people with HIV, according to an exploratory analysis from a large international clinical trial primarily funded by the National Institutes of Health (NIH). There was no elevated MACE risk for the other antiretroviral drugs included in the analysis. The findings will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
NIH Statement on Preliminary Efficacy Results of Twice-Yearly Lenacapavir for HIV Prevention in Cisgender Women
June 26, 2024
The injectable antiretroviral drug lenacapavir was safe and 100% effective as long-acting HIV pre-exposure prophylaxis (PrEP) among cisgender women in a Phase 3 clinical trial, according to top-line findings released by Gilead Sciences, Inc., the study sponsor. Lenacapavir is administered every six months, making it the most durable HIV prevention method to have shown efficacy in this population.
U.S. Clinical Trials Begin for Twice-Yearly HIV Prevention Injection
June 4, 2024
Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN).
Children Surpass a Year of HIV Remission after Treatment Pause
March 6, 2024
Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. The children, who acquired HIV before birth, were enrolled in a clinical trial funded by the National Institutes of Health in which an ART regimen was started within 48 hours of birth and then closely monitored for drug safety and HIV viral suppression.
Long-Acting HIV Treatment Benefits Adults with Barriers to Daily Pill Taking and Adolescents with Suppressed HIV
March 6, 2024
Long-acting, injectable antiretroviral therapy (ART) suppressed HIV replication better than oral ART in people who had previously experienced challenges taking daily oral regimens and was found safe in adolescents with HIV viral suppression, according to two studies presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Both studies were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in collaboration with other NIH institutes.
Semaglutide Reduces Severity of Common Liver Disease in People with HIV
March 5, 2024
A weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD), according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. This is the first clinical trial of semaglutide for MASLD in people with HIV.
Vaginal Ring and Oral Pre-Exposure Prophylaxis Found Safe for HIV Prevention Throughout Pregnancy
March 5, 2024
The monthly dapivirine vaginal ring and daily oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine were each found to be safe for HIV prevention among cisgender women who started using one of them in their second trimester of pregnancy, according to findings presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Pregnant people are estimated to be three times more likely to acquire HIV through sexual intercourse than similarly aged people who are not pregnant.
Statement: Long-Acting HIV Treatment Demonstrates Efficacy in People with Challenges Taking Daily Medicine as Prescribed
February 21, 2024
Long-acting antiretroviral therapy (ART) with cabotegravir and rilpivirine was superior in suppressing HIV replication compared to daily oral ART in people who had been unable to maintain viral suppression through an oral daily regimen, according to interim data from a randomized trial. Upon review of these findings, an independent Data and Safety Monitoring Board (DSMB) recommended halting randomization and inviting all eligible study participants to take long-acting ART.
NIH-Developed HIV Antibodies Protect Animals in Proof-of-Concept Study
January 17, 2024
Three different HIV antibodies each independently protected monkeys from acquiring simian-HIV (SHIV) in a placebo-controlled proof-of-concept study intended to inform development of a preventive HIV vaccine for people. The antibodies—a human broadly neutralizing antibody and two antibodies isolated from previously vaccinated monkeys—target the fusion peptide, a site on an HIV surface protein that helps the virus fuse with and enter cells.
NIH Research Identifies Opportunities to Improve Future HIV Vaccine Candidates
December 14, 2023
An effective HIV vaccine may need to prompt strong responses from immune cells called CD8+ T cells to protect people from acquiring HIV, according to a new study from researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and colleagues. The study findings, appearing in Science, draw comparisons between the immune system activity of past HIV vaccine study participants and people with HIV who naturally keep the virus from replicating even in the absence of antiretroviral therapy (ART).
Clinical Trial of HIV Vaccine Begins in United States and South Africa
September 20, 2023
A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.
Experimental HIV Vaccine Regimen Safe but Ineffective, NIH Study Finds
January 18, 2023
An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. The HPX3002/HVTN 706, or “Mosaico,” Phase 3 clinical trial began in 2019 and involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America.