Currently, treatment guidelines recommend the use of at least two active anti-HIV drugs (drugs that your HIV is not resistant to). Because the virus you are infected with is resistant to many of the currently approved drugs, this study will include new types of drugs. We hope that one of these new combinations of anti-HIV drugs will be able to lower your viral load. Treatment guidelines also recommend the use of at least two NRTIs to help lower your viral load. Some people have bad side effects from NRTIs, so we would like to see if NRTIs are always necessary.
This study is also being done to test a new way of predicting how well drugs will work for a particular person. Doctors on the study team will study the results from a resistance test (a test to see how certain anti-HIV drugs, including the study drugs, might work to control your viral load) and a tropism assay (another test that shows whether one of the study drugs, maraviroc, might be able to control your viral load) along with information from your medical history. The medical history information includes what drugs you have taken in the past and whether you have ever had any bad effects from other drugs. Then the doctors will identify one or more of the study regimens as the best option(s) for you.
Inclusion Criteria
- HIV positive men and women, 18 years of age or older.
- Triple-class experience or resistance at any time including prior use of more than one NRTI for at least 3 months and prior use of at least one NNRTI for at least 3 months OR demonstration of at least one mutation from each of the NRTI and NNRTI on any resistance assay (see study coordinator).
- Currently on a failing PI-containing regimen that includes at least 2 other ARVs besides the PI, with no regimen change for the 8 weeks prior to screening (An alteration in dose, dose frequency, or any within-class substitution(s) for intolerance is permitted).
- Viral load greater than or equal to 1000 copies/mL within 30 days of study entry
- Willingness of both male and female participants to practice at least two reliable methods of contraception for the duration of the study and for 6 weeks after the completion of the study.
- Laboratory values within normal ranges.
Exclusion Criteria
- Chronic, active hepatitis B or known allergy or sensitivity to study medications or other medications combined with study medications.
- Women who are pregnant or breastfeeding.
- Prior exposure to any integrase inhibitor,
- Certain prohibited medications such as anticonvulsants, antihistamines, certain TB medications, cholesterol lowering medications and others (see study coordinator).
This study is being conducted by Dr. Raphael Landovitz under IRB #07-10-011-01
If you think you might be interested in participating in this study, please contact Deon Claiborne at 310-557-9062 or email at dclaiborne@mednet.ucla.edu
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