What is an investigational drug?
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.
What is TMC-310911?
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.)
How are clinical trials of investigational drugs conducted?
Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.5
- Phase I trials: Researchers test an investigational drug in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
- Phase II trials: The investigational drug is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
- Phase III trials: The investigational drug is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational drug to be used safely.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
In what phase of testing is TMC-310911?
TMC-310911 has been studied in a Phase II clinical trial.2
What are some studies on TMC-310911?
Study Name: NCT00838162
Sponsor: Tibotec Pharmaceuticals, Ireland
Phase: IIa
Location: Germany
Participants:
- The study involved HIV-infected adults who had never taken HIV medicines before entering the study (also called treatment-naive).
- All participants had been HIV-positive for at least 6 months before the beginning of the study.
- The participants had viral load levels (the amount of HIV in a blood sample) of more than 5,000 copies/mL and CD4 counts above 200 cells/mm3. (A CD4 count is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function. The CD4 count of a healthy person ranges from 500 to 1,600 cells/mm3.)
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.
What side effects might TMC-310911 cause?
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.
Where can I get more information about clinical trials studying TMC-310911?
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.
I am interested in participating in a clinical trial of TMC-310911. How can I find more information about participating in a clinical trial?
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.
References
- United States National Library of Medicine. ChemIDplus Advanced. Available at: http://chem.sis.nlm.nih.gov/chemidplus/rn/1000287-05-7. Last accessed on October 13, 2016.
- National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Available at: http://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Last accessed on October 13, 2016.
- Stellbrink HJ, Arastéh K, Schürmann D, et al. Antiviral Activity, Pharmacokinetics, and Safety of the HIV-1 Protease Inhibitor TMC310911, Coadministered With Ritonavir, in Treatment-Naive HIV-1–Infected Patients. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):283-9. Available at: http://journals.lww.com/jaids/Fulltext/2014/03010/Antiviral_Activity,_Pharmacokinetics,_and_Safety.6.aspx. Last accessed on October 13, 2016.
- Dierynck I, Van Marck H, Van Ginderen M, et al. TMC310911, a Novel Human Immunodeficiency Virus Type 1 Protease Inhibitor, Shows In Vitro an Improved Resistance Profile and Higher Genetic Barrier to Resistance Compared with Current Protease Inhibitors. Antimicrob Agents Chemother. 2011 Dec; 55(12): 5723–5731. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232804/. Last accessed on October 13, 2016.
- National Institutes of Health (NIH). NIH Clinical Research Trials and You. Available at: http://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on October 13, 2016.
- Tibotec Pharmaceuticals, Ireland. A Phase IIa, Open-label, Randomized Trial in Treatment-naive HIV-1-infected Subjects to Determine the Antiviral Activity of 14 Days of Monotherapy With 4 Different Dose Regimens of TMC310911 Coadministered With Ritonavir. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 5, 2009. NLM Identifier: NCT00838162. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00838162. Last accessed on October 13, 2016.
Last Reviewed: October 13, 2016
