HIV-Positive Patients With Cancer Need to Be Included in Clinical Drug Trials

June 23, 2020

By Charles Kohler, a spokesperson for the U.S. Food and Drug Administration

Viral infections such as HIV may increase ( a person’s risk for developing several malignancies. However, most investigational drug studies exclude ( HIV-positive patients with cancer and optimal treatment regimens remain unknown.

Although HIV can be chronically managed with antiretroviral therapy (ART), combining ART and chemotherapy may result ( in adverse drug reactions that alter ART’s effects. HIV-positive patients with cancer have worse survival rates ( compared to patients with cancer who aren’t HIV-positive.

Expanding cancer clinical trial eligibility to be more inclusive of patients with viral infections is justified in many cases. It may accelerate the development of effective cancer therapies for patients with chronic infections, and inclusion promotes the safe and effective use of FDA-approved products across a broader patient population likely to use the drugs in clinical practice. As treatments for both HIV and cancer improve, researchers need to understand and study how they intersect so healthcare practitioners and patients can be adequately informed about their options.

FDA has been involved in many initiatives to expand eligibility criteria for clinical trials in oncology. In 2019, the agency put out a draft guidance—“Cancer Clinical Trial Eligibility Criteria: Patients With HIV, Hepatitis B Virus, or Hepatitis C Virus Infections”—to encourage rational inclusion of patients with HIV in clinical trials for oncology drugs. This will allow for greater understanding of treatment outcomes in this patient population as well as the opportunity for an HIV-positive patient with cancer to receive investigational drugs.

One of the most important aspects of our fight against HIV and AIDS has been to engage and work with patient communities to ensure that their voices are heard and their experiences inform our guidance and policy.

Oncology nurses can get involved through various public workshops and FDA outreach activities. FDA also educates healthcare providers through adequate labeling and safety communications associated with safe and effective use of the products we review.

Furthermore, FDA’s email list serve has more than 55,000 subscribers and provides HIV updates on product approvals, labeling changes, safety warnings, notices for upcoming meetings, and proposed regulatory guidance. Click here ( to join the list serve, visit.

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