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
Overview
- Phase
- Not Applicable
- Intervention
- Tenofovir + emtricitabine + raltegravir.
- Conditions
- HIV Infection
- Sponsor
- Kirby Institute
- Enrollment
- 16
- Locations
- 4
- Primary Endpoint
- Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
The study is an open-label study of 3-years duration. This study will be conducted at 4 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 three years with intensive quantification of both plasma RNA and cell associated DNA viral species.
Investigators
Sally Hough
Senior Clinical Project Coordinator
Kirby Institute
Eligibility 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.
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
- •phenytoin
- •phenobarbital
Arms & Interventions
antiretroviral therapy
tenofovir (TDF) + emtricitabine (FTC) as a fixed dose combination administered orally once per day and raltegravir (RAL) administered orally twice per day.
Intervention: Tenofovir + emtricitabine + raltegravir.
Outcomes
Primary Outcomes
Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
Time Frame: 12 times within 48 weeks.
change was calculated as the mean of 12 assessments minus the baseline value