Activists have long pushed for clinical trials that combine two new drugs for people who have no active agents, and one company, Tibotec, has recently begun the first such trials, of a protease inhibitor, darunavir (TMC 114), and an NNRTI, etravirine (TMC 125).
The DUET studies allow patients to take both of these drugs, although people will be randomized to receive etravirine or placebo. So there still is a 50% chance of receiving virtual monotherapy if you have no other active drugs available. (People randomized to receive only darunavir can add etravirine after 6 months if their viral load is not controlled.)
If your genotype test shows that your HIV is resistant to most approved anti-HIV drugs and you and your health care provider feel you must change your regimen, here are some options. (Not everyone who is resistant to their meds needs to switch; there may be good reasons not to.)
- Get a phenotype test to find out exactly what medications you have resistance to. Your doctor may also take into consideration your treatment history to determine Fuzeon resistance and the potential for archived resistance.
- If you have at least one active drug available, talk to your doctor about the DUET studies or the darunavir Expanded Access Program (866-889-2074).
- If your CD4 count is very low (under 50, for example), and you feel you cannot risk being on virtual monotherapy by joining the DUET studies, ask your doctor to contact Tibotec at firstname.lastname@example.org to discuss a Single Patient IND (investigational new drug) for etravirine, along with the darunavir EAP.
- Wait for trials of experimental integrase inhibitors. Merck's trials of MK518 are open now, and Gilead's trials of GS 9137 will open soon (check trialsearch.org for details). The Merck trial provides a 33% chance to be on approved drugs only.
- Wait until darunavir gets approved (hopefully in the next few months), and MRK 518 becomes available through an expanded access program, hopefully later this year.