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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine; Raltegravir Potassium; Tenofovir

Criteria

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 < 1.5 x ULN.

• Serum alkaline phosphatase < 3 X ULN.

• Serum aspartate aminotransferase (AST) < 3 X ULN.

• Serum alanine aminotransferase (ALT) < 3 X ULN.

• Creatinine clearance > 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.