The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection

Inclusion Criteria

• Age at least 18 years.
• Provision of written, informed consent.
• Screening plasma HIV RNA > 10, 000 copies/mL.
• Screening CD4+ T lymphocyte count > 100 x 10^6)/L.
• No previous antiretroviral therapy.
• Haemoglobin > 115 g/L (female) or > 130 g/L (male).
• Absolute neutrophil count > 1 x 10^9/L.
• Platelet count > 100 x 10^9/L
• Serum bilirubin 50mL/min (Creatinine clearance (mL/min) =140 - age x weight creatinine Multiply the result by 1.2 for men).

Cohort A: Primary HIV infection:

Documented acute or early infection diagnosed by:

Acute infection:

< 3 bands on Western Blot and any one of: i. positive p24 antigen ii. positive proviral DNA

Early infection:

i. Positive detuned or BED ELISA result OR ii. Previously negative serology within 6 months of confirmed positive serology.

Cohort B: Chronic HIV infection:

Documented HIV-infection of at least 12 months duration.

Exclusion Criteria

• Pregnancy or breastfeeding.
• Receipt of investigational products within 1 month of study entry.
• Receipt of any of the following within 6 months of study entry:
• interferon alpha or gamma
• oral corticosteroids (inhaled or topical corticosteroids are permitted)
• cyclosporin
• alkylating agents
• other immunosuppressive agents
• rifampin
• phenytoin
• phenobarbital
• Documented genotypic (IAS 2007) resistance to tenofovir or emtricitabine from any HIV drug resistance test.
• Any medications contraindicated with Truvada or raltegravir.
• Significant intercurrent illnesses apart from HIV infection such as viral hepatitis (diagnosed by core hepatitis B antigen and/or positive hepatitis B PCR or positive hepatitis C PCR) or any other condition which in the opinion of the investigator would compromise participation in the study.
• History of non-traumatic osteoporotic fracture.