NIH Tells HIV and Tuberculosis Trial Networks to Delay New Studies as Funding Renewal Notices Stall at HHS

NIH Tells HIV and Tuberculosis Trial Networks to Delay New Studies as Funding Renewal Notices Stall at HHS

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On Oct. 2, the National Institutes of Health told HIV researchers to temporarily pause new studies that had not yet enrolled participants and would not be complete by Nov. 30, 2027, when the networks’ current funding expires, according to The New York Times report on the renewal delays.

The networks’ next funding cycle depends on renewal notices that have not been released. The government had said the notices would be posted by late August, but they had not appeared as of Oct. 7, the Times reported. A federal official said the notices were under review at the Department of Health and Human Services (HHS), which is led by Secretary Robert F. Kennedy Jr. Scientists told the newspaper they worry the delays could end the networks, at least in their current form, according to a KFF Health News summary of the report.

HHS said the administration plans to continue investing in HIV research that delivers meaningful results, but it has not confirmed whether the renewal process will move forward.

The affected networks are the AIDS Clinical Trials Group, now known as Advancing Clinical Therapeutics Globally (ACTG); the HIV Prevention Trials Network (HPTN); the HIV Vaccine Trials Network (HVTN); and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), which studies infants, children, adolescents, and pregnant people. Together, they account for more than $300 million a year, mostly from the federal government, according to the Times.

NIH restructured its HIV clinical trials networks in 2020 and gave them seven-year awards. Under those awards, HVTN is led from Fred Hutchinson Cancer Center in Seattle, HPTN from FHI 360 in Durham, North Carolina, ACTG from the University of California, Los Angeles, and IMPAACT from Johns Hopkins University in Baltimore.

By early September, NIH had released renewal notices for its other infectious disease clinical trial networks, while notices for the HIV networks and the Centers for AIDS Research (CFARs) remained pending. In a joint statement, the Infectious Diseases Society of America and HIV Medicine Association said the “ongoing delays in the renewals for the pioneering CFARs and HIV clinical trial networks are alarming.”

The statement, signed by IDSA President Dr. Ronald G. Nahass and HIVMA Chair Dr. Anna K. Person, warned that “Destabilizing NIAID’s HIV research infrastructure will harm study participants.” NIAID is the National Institute of Allergy and Infectious Diseases, the NIH institute that funds the networks. The groups urged NIH to promptly issue the funding notices and to extend existing awards where needed so ongoing trials are not lost. They also raised concerns about a proposed overhaul of NIAID’s clinical research program that NIH announced Aug. 28, saying it offered few details and a brief comment period.

The funding uncertainty is not new. In May 2025, the advocacy group Treatment Action Group said NIH was withholding funds from the same four HIV networks, warning that the move threatened protections for people enrolled in trials.

The NIH instruction applies to new studies that have not enrolled participants, not to ongoing trials. People already in a study who have questions about their visits, medicines, or follow-up schedule should ask their study team.

The longer-term concern is for future research. Because large trials take years to design and complete, studies that cannot finish before November 2027 may be delayed. With IMPAACT focused on children and pregnant people, those groups could face a longer wait for new evidence on HIV treatment and prevention.

An estimated 1.2 million people in the U.S. were living with HIV at the end of 2022, according to federal HIV statistics. The pause does not change current HIV care, and no one should stop HIV medicine or PrEP (medicine that prevents HIV) without talking with a clinician. People interested in joining a study can search ClinicalTrials.gov for trials that are currently enrolling.

What did NIH tell the networks? On Oct. 2, NIH told HIV researchers to hold off on new studies that had not enrolled participants and would not be complete by Nov. 30, 2027, when current funding expires.

Which networks are affected? The four networks are ACTG, HPTN, HVTN, and IMPAACT, which study HIV treatment, prevention, and vaccines, as well as care for children and pregnant people.

Are current trial participants affected? The instruction applies to new studies that have not enrolled anyone. Participants should confirm their schedules with their study team.

Why is the funding delayed? The renewal notices, expected by late August, are under review at HHS. HHS has not confirmed whether the renewal process will move forward.

Should patients change their HIV care? No. People should not stop HIV treatment or PrEP without talking with a clinician.

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Reported by medicaldaily.com.

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