NIH study digs into why HIV drugs stop working for some patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: 1. Age, greater than or equal to 18 years. 2. Documented HIV-1 infection (prior written documentation such as positive standard ELISA or rapid HIV-1/HIV-2 antibody test with confirmatory Western Blot, or documentation of repeated HIV RNA of greater than 1,000 copies/mL).. 3. Established care with an HIV primary care provider. 4. Fulfilling one of the following criteria for virologic failure: 1. Documented virologic failure on at least 1 prior ART regimen and at least 2 consecutive HIV RNA plasma measurements of greater than 1,000 copies/mL, including the last documented value, while on the current prescribed ART regimen for at least 6 months; or 2. Documented extensive resistance to at least 3 ARV drug classes, and has persistent plasma viremia (HIV RNA greater than 1,000 copies/mL for greater than 6 months) despite multiple regimen changes, regardless of how long the subject has been prescribed his or her current regimen. 5. Willingness to have samples stored for future research. 6. Willingness to undergo genetic testing. 7. Ability and willingness to provide informed consent 8. Willingness to be hospitalized for iDOT or record videos of themselves for eDOT. EXCLUSION CRITERIA: 1. HIV RNA levels at screening \<1,000 copies/mL. 2. Receiving medical care for an acute medical illness stemming from a significant comorbidity; enrollment may be deferred or postponed until the condition resolves or stabilizes. 3. Pregnancy (if a subject becomes pregnant while enrolled in the protocol, she will continue participation throughout her pregnancy). 4. Any illness or condition that, in the investigator s opinion, may substantially increase the risk associated with the subject s participation in the study, or may compromise the scientific objectives. NOTE: Participants will not be excluded based on stable laboratory abnormalities, hepatitis B virus (HBV) or hepatitis C virus (HCV) co-infection status, etc. Selection of a new ART regimen will account for any co-existing conditions, such as known risks of antiretroviral drugs to the fetus, dosage adjustment due to organ dysfunction, drug interaction potential with concomitant agents, and the need for treatment of HBV co-infection.