Since 2014, Treatment Action Group’s website has featured a regularly updated listing of clinical trials and observational studies related to the scientific effort to develop a cure for HIV infection. Clinical trials typically involve the administration of experimental interventions, whereas observational studies only require blood draws or other sampling.
The listing is almost entirely dependent on online clinical trial registries, particularly the US-based clinicaltrials.gov (we search the registries every month to look for new HIV cure-related research). Studies are included based on the registry descriptions and the outcomes being measured (called study endpoints), with measurements of the HIV reservoir representing the most common reason for inclusion. Wherever possible, each listing entry features a link to a registry page where you can find details on the study, including contact information for the researchers and inclusion and exclusion criteria for potential participants.
Information is divided into three tables: current clinical trials, current observational studies, and completed studies. The completed studies table focuses mainly on investigations conducted since HIV cure research emerged as a specific field, after the case of Timothy Ray Brown was first reported in 2008 (for example, historical early studies of gene therapies and therapeutic HIV vaccines that didn’t have a cure focus are omitted).
Maintenance of clinical trial registry entries is the responsibility of study sponsors and not within our control. Phase I trials are not required to be registered and some sponsors—most notably Gilead Sciences—consistently fail to register their phase I HIV cure-related studies. We encourage all researchers and sponsors to register their studies and keep the entries as up to date as possible because it greatly helps efforts to provide current information on the spectrum of HIV cure-related clinical research.
If a registry entry is not updated for an extended period, we contact the researchers to attempt to ascertain the status of the study. In the absence of a reply, we typically leave a grace period of around six months before moving the entry to the completed studies table. Out of date listings are only retained as current if we have direct information from the researchers that the study is open.
When our table indicates that a study is recruiting participants, but the respective registry entry does not, this is because we have received more recent information from the researchers to confirm that they are open for enrollment.
There is a considerable amount of HIV cure research taking place, so the listing is lengthy and complex. Current clinical trials are broken down into broad categories of interventions as a way to bring some organization to the list (e.g. antibodies, gene therapies, etc.).
More information on the types of interventions currently being studied in HIV cure research can be found in the CUREiculum module HIV Cure-Related Strategies. A more technical overview is provided in the published article Research priorities for an HIV cure: International AIDS Society Global Scientific Strategy 2021, which also has an accompanying community explainer from HIV i-Base.
Please send updates, corrections, suggestions, information on broken links or requests for additional information to Richard Jefferys at richard.jefferys@treatmentactiongroup.org.