None listed
Conditions
Brief summary
An open label study to examine the characteristics of HIV decay following introduction of combination antiretroviral therapy including raltegravir during primary and chronic HIV infection.
Interventions
The study is an open-label study of 1-year duration. This study will be conducted at 5 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiretroviral therapy (ART) naïve and will commence a regimen of combination ART consisting of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibi
The study is an open-label study of 1-year duration. This study will be conducted at 5 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiretroviral therapy (ART) naïve and will commence a regimen of combination ART consisting of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir. Subjects will be followed for one year with intensive quantification of both plasma Ribonucleic acid (RNA) and cell associated Deoxyribonucleic acid (DNA) viral species. Truvada (FTC 200mg + TDF 300mg) once daily plus Isentress (raltegravir 400mg) twice daily.
Sponsors
National Centre in HIV Epidemiology and Clinical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 106/L. •No previous antiretroviral therapy. •Haemoglobin > 115 g/L (female) or > 130 g/L (male). •Absolute neutrophil count > 1 x 109/L. •Platelet count > 100 x 109/L •Serum bilirubin < 1.5 x upper limit normal (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 B + E + D enzyme linked immuno-sorbent assay (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: o interferon a or ? o oral corticosteroids (inhaled or topical corticosteroids are permitted) o cylcosporin o alkylating agents o other immunosuppressive agents o rifampin o phenytoin o phenobarbitol •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.
Outcome results
None listed