NCT00885664

Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are: 1. To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects. 2. To determine whether these side effects can be related to greater activation of the immune system.

Detailed description

1. To compare the incidence and severity of self-reported symptoms in persons with CD4 counts \<100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy. 2. To determine the relationship between self-reported symptoms and levels of T cells, HIV RNA, activation marker cytokines including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10 and other cytokines as measured before and after the initiation of antiretroviral therapy. 3. To determine the relationship between antiretroviral drug trough levels (estimated drug concentrations) and the incidence and severity of self-reported symptoms in persons initiating antiretroviral therapy. 4. To determine the relationship between adverse events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels. 5. To determine the relationship between clinical events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Truvada (tenofovir/emtricitabine)	Tenofovir/emtricitabine fixed dose combination once daily
DRUG	Kaletra (lopinavir/ritonavir)	Lopinavir/ritonavir 400/100 mg twice daily

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-09-01
• Completion: 2010-03-01
• First posted: 2009-04-22
• Last updated: 2022-08-10
• Results posted: 2022-08-10

Locations

1 site across 1 country: United States