The National Institutes of Health reported this week that it launched a clinical trial evaluating a combination of antibodies in people with HIV.
The early-stage study is designed to assess whether periodic infusions of two HIV-specific antibodies are safe in people living with HIV. Researchers also plan to gather preliminary data assessing how effectively the infusions suppress HIV after patients stop taking antiretroviral therapy.
“Antiretroviral therapy suppresses HIV to very low levels, normalizes life expectancy, and prevents sexual transmission of the virus. However, these benefits are lost if an individual stops taking the medications as prescribed,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in prepared remarks. “If proven safe and effective, periodic infusions of potent, broadly neutralizing HIV antibodies may be a potential alternative to daily antiretroviral therapy.”
“When we first began developing antiretroviral medications more than two decades ago, we found that HIV mutated to escape the effect of any single drug acting alone,” lead investigator Dr. Michael Sneller added. “However, we had remarkable success treating people with combinations of drugs, which targeted different parts of the HIV replication cycle,”
“Our group hypothesized that a combination approach to infusions of broadly neutralizing antibodies might also help avoid the development of resistance that has been observed following treatment with individual bNAbs,” he said.
The study is slated to enroll 30 people who began antiretroviral therapy (ART) during early HIV infection and 15 people whose HIV infections are advancing slowly even though they’re not taking ART.
In the first group, volunteers will stop taking ART after being randomized to receive either the antibodies or a saline placebo. Over the course of 24 weeks, this group will receive eight infusions. People will be restarted on ART if HIV levels in their blood rise above a particular threshold or if they develop any HIV-related symptoms.
The “slow progressors” in the second group will receive the combination antibody infusions but will remain without ART. Researchers plan to keep a close eye on participants in both groups and expect results in 2021.