NCT00641641

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Tenofovir + emtricitabine + raltegravir.	TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-03-01
• Completion: 2011-06-01
• First posted: 2008-03-24
• Last updated: 2017-08-31
• Results posted: 2013-05-27

Locations

4 sites across 1 country: Australia