The National Institutes of Health and partners today announced plans to conduct a Phase 3 HIV vaccine efficacy trial at multiple clinical research sites in North America, South America and Europe. The trial, called HPX3002/HVTN 706 or Mosaico, will assess whether an investigational vaccine regimen designed to induce immune responses against a variety of global HIV strains can safely and effectively prevent HIV acquisition among men who have sex with men and transgender people.
DAIDS (Division of AIDS) News Releases
A large clinical trial to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB) has begun. The study is comparing the safety and efficacy of a new MDR-TB drug, delamanid, with the decades-old TB drug isoniazid for preventing active MDR-TB disease in children, adolescents and adults at high risk who are exposed to adult household members with MDR-TB.
Since the first cases of what would become known as HIV/AIDS were initially reported in 1981, scientists and public health officials have been working to better understand HIV, develop strategies to effectively treat and prevent infection, and bring about an end to the pandemic. This effort remains a critical focus globally and for the United States.
Eighty-six percent of individuals who entered HIV care soon after diagnosis maintained viral suppression after 48 weeks during a clinical trial conducted at four National Institutes of Health (NIH)-funded Centers for AIDS Research (CFARs) across the United States. Participants in the clinical trial, called iENGAGE, achieved viral suppression in an average of just 63 days.
New HIV infections declined by 30 percent in southern African communities where health workers conducted house-to-house voluntary HIV testing, referred people who tested positive to begin HIV treatment according to local guidelines, and offered other proven HIV prevention measures to those who tested negative. Local guidelines evolved during the study from offering HIV treatment based on immune health to offering immediate treatment for all.
A clinical trial has begun to examine the safety and use of two HIV prevention tools—oral pre-exposure prophylaxis (PrEP) and a vaginal ring—in adolescent girls and young women in southern Africa. Funded by the National Institutes of Health, the trial is designed to contribute to the delivery of safe, effective and desirable choices of HIV prevention methods for adolescent girls and young women, who are disproportionately affected by the HIV epidemic.
Scientists funded by the National Institutes of Health have developed a new assay to accurately and easily count the cells that comprise the HIV reservoir, the stubborn obstacle to an HIV cure. This advance will enable researchers who are trying to eliminate the HIV reservoir to clearly understand whether their strategies are working. The research was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.
In recent years, an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound, say officials from the National Institutes of Health. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others.
Each year on World AIDS Day, we reflect on the remarkable progress that has been made against HIV. Indeed, we have come a long way since the disease now known as AIDS was first reported in 1981.
A new commentary from National Institutes of Health scientists asserts that engaging men in HIV prevention and care is essential to the goal of ending the HIV pandemic. The article by Adeola Adeyeye, M.D., M.P.A., and David Burns, M.D., M.P.H., of the National Institute of Allergy and Infectious Diseases (NIAID) and Michael Stirratt, Ph.D., of the National Institute of Mental Health (NIMH) also discusses potential solutions.
An intervention designed to facilitate treatment for HIV and substance use was associated with a 50 percent reduction in mortality for people living with HIV who inject illicit drugs, a study has found. In addition, the people who received the intervention were nearly twice as likely to report being in treatment for HIV and substance use after one year as those who received their national standard of care. They also were about twice as likely to have suppressed their HIV to undetectable levels after one year.
Daily antiretroviral therapy (ART) that suppresses HIV to levels undetectable by standard blood tests is lifesaving for individuals living with HIV and prevents sexual transmission of the virus to others. The public health community must use targeted interventions, however, to do a better job of reaching populations with low levels of viral suppression, according to experts from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Long-lasting control of HIV infection without antiretroviral therapy (ART) is a feasible goal that deserves vigorous pursuit, Anthony S. Fauci, M.D., will assert during a lecture on Wednesday, July 25 at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam. Dr. Fauci directs the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health. His lecture is titled, “Durable Control of HIV Infection in the Absence of Antiretroviral Therapy: Opportunities and Challenges.”
People living with HIV in rural East African communities that hosted annual community health campaigns initiated antiretroviral therapy (ART) earlier and had higher levels of overall survival and viral suppression than communities receiving standard HIV care, according to study data presented today at a press conference at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam.
Nearly 90 percent of participants in an open-label study of a vaginal ring infused with a drug to prevent HIV are using the monthly ring at least some of the time, according to an interim analysis of study data. In addition, the rate of HIV infection among participants in the open-label study, which has no placebo arm for comparison, is half of what might be expected in the absence of the ring, according to mathematical modeling that has significant limitations.
A one-month antibiotic regimen to prevent active tuberculosis (TB) disease was at least as safe and effective as the standard nine-month therapy for people living with HIV, according to the results of a large international clinical trial. Adults and adolescents in the trial were more likely to complete the short-course regimen—consisting of daily doses of the antibiotics rifapentine and isoniazid for four weeks—than the standard nine-month regimen of daily isoniazid.
For the first time, scientists have shown a relationship between the proportion of key immune cells that display high levels of a gut-homing protein called alpha-4 beta-7 at the time of HIV infection and health outcomes. Previous research illustrated this relationship in monkeys infected with a simian form of HIV.
The National Institutes of Health has launched a large international study to compare the safety and efficacy of three antiretroviral treatment regimens for pregnant women living with HIV and the safety of these regimens for their infants. The study will evaluate the current preferred first-line regimen for pregnant women recommended by the World Health Organization (WHO) and two regimens containing newer antiretroviral drugs that are becoming more widely used.
Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious DiseasesMaureen M. Goodenow, Ph.D., Director, Office of AIDS Research
The first large-scale clinical trial of a long-acting injectable medication for HIV prevention in sexually active women has begun. The study in southern and eastern Africa will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every eight weeks can safely protect women at risk for HIV infection. The only drug regimen currently licensed for HIV pre-exposure prophylaxis, or PrEP, is the anti-HIV medication Truvada taken daily as an oral tablet. The U.S.
The National Institutes of Health and partners have launched a large clinical trial to assess whether an experimental HIV vaccine regimen is safe and able to prevent HIV infection. The new Phase 2b proof-of-concept study, called Imbokodo, aims to enroll 2,600 HIV-negative women in sub-Saharan Africa. Of 1.8 million new HIV infections worldwide in 2016, 43 percent occurred in eastern and southern Africa, with women and girls disproportionately affected.
A study published today in the New England Journal of Medicine provides real-world evidence that implementing a combination of proven HIV prevention measures across communities can substantially reduce new HIV infections in a population.
Investigators found that HIV incidence dropped by 42 percent among nearly 18,000 people in Rakai District, Uganda, during a seven-year period in which the rates of HIV treatment and voluntary medical male circumcision increased significantly.
A monthly vaginal ring and a daily oral tablet, both containing anti-HIV drugs, were safe and acceptable in studies of adolescents, two teams of investigators reported today at the 9th IAS Conference on HIV Science in Paris. The experimental ring is designed for HIV prevention and the oral tablet is already used for this purpose in adults. Adherence to the ring was high, while adherence to the tablet was moderate and diminished substantially when study visits became less frequent.
Transgender women—people whose birth certificates indicate or once indicated male sex but who identify as women—are at high risk of HIV acquisition, and thus are a key population for HIV prevention and treatment efforts.
A nine-year-old South African child who was diagnosed with HIV infection at one month of age and received anti-HIV treatment during infancy has suppressed the virus without anti-HIV drugs for eight and a half years, scientists reported today at the 9th IAS Conference on HIV Science in Paris. This case appears to be the third reported instance of sustained HIV remission in a child after early, limited anti-HIV treatment.
Results from an early-stage clinical trial called APPROACH show that an investigational HIV vaccine regimen was well-tolerated and generated immune responses against HIV in healthy adults. The APPROACH findings, as well as results expected in late 2017 from another early-stage clinical trial called TRAVERSE, will form the basis of the decision whether to move forward with a larger trial in southern Africa to evaluate vaccine safety and efficacy among women at risk of acquiring HIV.
Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious DiseasesCarl W. Dieffenbach, Ph.D., Director, Division of AIDS, NIAID
Statement of Christine F. Sizemore, PhD., Richard Hafner, M.D., and Anthony S. Fauci, M.D. National Institute of Allergy and Infectious DiseasesNational Institutes of Health
Giving monkeys two powerful anti-HIV antibodies immediately after infection with an HIV-like virus enabled the immune systems of some of the animals to control the virus long after the antibodies were gone, scientists at the National Institutes of Health and The Rockefeller University have found.
The first large-scale clinical trial of a long-acting injectable drug for HIV prevention began today. The study, sponsored by the National Institutes of Health, will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every 8 weeks can safely protect men and transgender women from HIV infection at least as well as the anti-HIV medication Truvada taken daily as an oral tablet.
Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious DiseasesCarl W. Dieffenbach, Ph.D., Director, Division of AIDS, NIAID
The first HIV vaccine efficacy study to launch anywhere in seven years is now testing whether an experimental vaccine regimen safely prevents HIV infection among South African adults. The study, called HVTN 702, involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. HVTN 702 aims to enroll 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial to take place in South Africa, where more than 1,000 people become infected with HIV every day.
Infusions of an anti-HIV antibody known as VRC01 were shown to be safe and maintained intended antibody concentrations in the blood of people living with HIV, according to two related studies by scientists at the National Institutes of Health (NIH) and the AIDS Clinical Trials Group (ACTG). The antibody modestly suppressed blood levels of HIV in people who stopped taking antiretroviral therapy (ART), but the delay in the reappearance of virus was not clinically significant.
Achieving moderate reduction of new HIV infections among men who have sex with men (MSM) will depend on significantly increasing the percentage of HIV-infected MSM whose viral load is suppressed to undetectable levels, according to a new mathematical model based on data from Baltimore. Access and adherence to antiretroviral therapy are key to sustained HIV suppression, which dramatically reduces the risk of transmitting HIV to others.
Most women who used an experimental vaginal ring for HIV prevention report that the physical act of sex was largely unaffected by using the product, which is inserted monthly for continuous wear. This finding is among several insights gleaned about experiences of women who used the ring during the ASPIRE study, also known as MTN-020, announced today at the HIV Research for Prevention (HIVR4P) meeting in Chicago.
Scientists at the National Institutes of Health (NIH) and Emory University have experimentally induced sustained remission of SIV, the simian form of HIV, in infected monkeys. The animals’ immune systems have been suppressing the virus to undetectable levels for as long as 23 months since the monkeys completed an investigational treatment regimen. In addition, the regimen has led to the near-complete replenishment of key immune cells that SIV had destroyed, something unachievable with antiretroviral therapy (ART) alone. The findings will be published in the Oct.
People living with HIV who naturally produce broadly neutralizing antibodies (bNAbs) that may help suppress the virus have different immunological profiles than people who do not, researchers report. While bNAbs cannot completely clear HIV infections in people who have already acquired the virus, many scientists believe a successful preventive HIV vaccine must induce bNAbs
A new exploratory analysis of data from the ASPIRE study has found that using a drug-infused vaginal ring most or all of the time reduced the risk of HIV infection in women by at least 56 percent. This finding is being reported today at a press briefing at the 21st International AIDS Conference (AIDS 2016) in Durban, South Africa, and will be presented in more detail tomorrow in a lecture at the conference.
The National Institutes of Health has awarded approximately $30 million in annual funding over the next five years to six research collaborations working to advance basic medical science toward an HIV cure. The awards comprise the second iteration of the Martin Delaney Collaboratory: Towards an HIV-1 Cure program and are a part of President Barack Obama’s pledge to invest in HIV cure research.
An early-stage HIV vaccine clinical trial in South Africa has determined that an investigational vaccine regimen is safe and generates comparable immune responses to those reported in a landmark 2009 study showing that a vaccine can protect people from HIV infection.
Enrollment into a clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID) investigating two different strategies to treat limited-stage AIDS-related Kaposi’s sarcoma was stopped due to futility—if continued, the study would be unlikely to detect a difference between the two study arms.
New research in monkeys exposed to SIV, the monkey equivalent of HIV, suggests that the virus spreads rapidly in the body and triggers early host responses that suppress antiviral immunity, thus promoting viral replication. The study, published in Cell, provides a detailed view of the period between initial mucosal exposure to the virus and the point at which it becomes detectable in the blood.
Enrollment has begun in the first of two multinational clinical trials of an intravenously delivered investigational antibody for preventing HIV infection. Known as the AMP Studies, for antibody-mediated prevention, the trials will test whether giving people an investigational anti-HIV antibody called VRC01 as an intravenous infusion every 8 weeks is safe, tolerable and effective at preventing HIV infection.
A clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID) comparing three advanced Kaposi’s sarcoma chemotherapy regimens in combination with antiretroviral treatment (ART) for patients with AIDS will no longer enroll participants in the study arm testing the oral chemotherapy drug etoposide.
Maraviroc, an oral drug used to treat HIV infection, is safe and well-tolerated when taken daily as pre-exposure prophylaxis (PrEP) to prevent HIV infection by HIV-uninfected men who have sex with men (MSM) at increased risk for acquiring HIV.
New findings suggest that black men who have sex with men (BMSM) with access to a novel coordinated care program can adhere to pre-exposure prophylaxis (PrEP), a medication regimen that helps prevent HIV infection in uninfected individuals.
The slight loss in bone mineral density associated with HIV pre-exposure prophylaxis (PrEP) antiretroviral use is reversible in young adult patients who stop taking the drugs, according to findings presented by researchers today at the 23rd Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
A ring that continuously releases an experimental antiretroviral drug in the vagina safely provided a modest level of protection against HIV infection in women, a large clinical trial in four sub-Saharan African countries has found.
In HIV-infected patients undergoing antiretroviral therapy (ART), ongoing HIV replication in lymphoid tissues such as the lymph nodes helps maintain stores, or reservoirs, of the virus, a new study funded by the National Institutes of Health suggests.