A5413: Dasatinib for HIV-1 Reservoir Reduction

HIV Cure, Treatment Experienced

To determine if dasatinib is safe and well tolerated in people with HIV, and to see if dasatinib can reduce the amount of HIV in cells.

• To test if dasatinib is safe and well tolerated (this means that the side effects are not bad enough that you want to stop taking the drug) in people with HIV.
• To see if dasatinib can reduce the amount of HIV in the cells in your body that fight disease so that the virus doesn’t come back if you stop treatment.

• People living with HIV who have been on stable HIV treatment for at least 48 months (4 years)
• 18 years of age or older
• HIV levels in the blood (viral load) undetectable for at least 36 months (3 years) (small occasional increases in viral load may be allowed)
• CD4+ cell (a type of immune cell) count above 450 from a test done within 12 months or 1 year before joining the study
• Must not have started HIV treatment during the early (acute) phase of infection
• Must not be pregnant, planning to become pregnant during the study, or breastfeeding (women who could become pregnant must agree to use two forms of birth control if having sex that could result in pregnancy)

• You will be assigned to one of two groups, either dasatinib or placebo, by random selection, like flipping a coin.
• You will take the study drug (either dasatinib or a placebo capsule that looks like dasatinib) by mouth every day for 12 weeks. Neither you nor the researchers will know which medication you will be taking during the study. You will have 5 study visits during these 12 weeks.
• You will come to the clinic for a total of 9 study visits, starting with study entry to week 36.
• You will also come in for 3 study visits during the 24 weeks after stopping the study drug.
• At all visits you will have a physical exam and have blood drawn.
• At some visits, you might have a urine test.
• At some visits, you will have an EKG (electrocardiogram).

Oral dasatinib 100 mg capsules or matched placebo daily for 12 weeks

• Dasatinib is a drug that has been approved by the FDA to treat some cancers.
• The placebo in this study looks the same as dasatinib, but has no effect, like a “sugar pill.”
• You must continue your ART (regular drugs to control HIV) while you are on the study (these drugs will not be supplied by the study).

36 weeks

• Study Treatment: 12 Weeks
• Follow-up: 24 Weeks