Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE)

Inclusion Criteria:

• HIV-1 Infection
• HIV-1 RNA <50 copies/mL on all measurements within 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug antiretroviral regimen. (A history of switching for simplification and/or tolerability is allowed. At least two measurements within the previous 48 weeks are required prior to study screening.)
• No history of virologic failure, defined as consecutive HIV RNA > 50 copies/mL after 12 months of initiating ART. An isolated (non-consecutive) HIV RNA > 50 copies/mL (but less than 400 copies/mL) is permitted after 12 months of initiating ART but not in the 48-week window prior to study entry.
• Screening plasma HIV RNA < 20 copies/mL using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test V2.0, obtained within 45 days prior to study entry
• Nadir CD4 count >200 cells/mm
• Pretreatment genotype documenting no mutations in the protease or reverse transcriptase genes
• No known resistance to integrase inhibitors
• Laboratory values obtained within 45 days prior to study entry:

ANC >750 Hemoglobin >10 g/dL Platelets >50,000 Calculated creatinine clearance (CrCl) >50 mL/min

• Negative serum or urine pregnancy test
• Men and women age greater or equal to 18 years.
• Ability to continue current regimen (i.e, have uninterrupted access)
• No evidence of chronic hepatitis B

Exclusion Criteria:

• Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
• Treatment within 30 days prior to study entry with immune modulators
• Vaccination within 7 days
• Active HCV treatment or anticipated need for treatment within study period. (HCV infection alone is not exclusionary)
• Unstable liver disease or severe hepatic impairment
• Known allergy or hypersensitivity to DTG or lamivudine.
• Active drug or alcohol use or dependence that could interfere with adherence to study requirements
• ALT (alanine aminotransferase) >5 x ULN (upper limit of normal) OR ALT >3 x ULN and total bilirubin >1.5 x ULN (with 35% direct bilirubin)