An investigational drug is one that is under study and is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational drug. These research studies are also called clinical trials. Once an investigational drug has been proven safe and effective in clinical trials, FDA may approve the drug for sale in the United States.
To learn more about investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.
TMC-310911 is an investigational drug that is being studied for the treatment of HIV infection.
TMC-310911 belongs to a class (group) of HIV medicines called protease inhibitors (PIs).2 PIs block an HIV enzyme called protease. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking protease, PIs prevent HIV from multiplying and can reduce the amount of HIV in the body.
In vitro, TMC-310911 has been able to fight strains of HIV that are no longer affected by other PIs.4 (In vitro refers to studies done in test tubes or other laboratory equipment and not on animals or humans.)
Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.5
In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States. Some drugs go through FDA’s accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the drug’s risks, benefits, and optimal use.5
TMC-310911 has been studied in a Phase II clinical trial.2
Study Name: NCT00838162
Sponsor: Tibotec Pharmaceuticals, Ireland
Purpose: The purpose of this study was to evaluate the safety and effectiveness of TMC-310911 when given with a low dose of the medicine ritonavir.3,6
For more details on this study, see the Health Professional version.
In the Phase IIa study discussed under the previous question (NCT00838162), some of the most common side effects, which occurred in at least 10% of participants, were fatigue and nausea. Most side effects were mild to moderate in severity. Side effects related to the gastrointestinal system (such as nausea, diarrhea, and frequent bowel movements) occurred in more than 25% of all the study participants. (The gastrointestinal system involves the stomach and intestines.) One participant had a temporary increase in liver enzyme levels that may have been caused by TMC-310911.3
Because TMC-310911 is still being studied, information on possible side effects of the drug is not complete. As testing of TMC-310911 continues, additional information on possible side effects will be gathered.
More information about TMC-310911-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.5
Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.
Last Reviewed: October 13, 2016