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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Tenofovir/emtricitabine fixed dose combination once daily
Lopinavir/ritonavir 400/100 mg twice daily
University of Cincinnati AIDS Clinical Trials Unit
Cincinnati, Ohio, United States
Symptom Score
AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale.
Time frame: Week 4
SF-12 Physical Capacity Score
Measure of physical function out of 100. Lower score means less physical capacity.
Time frame: 4 weeks
SF-12 Mental Capacity Score
Measure of mental functioning where lower is better out of a scale of 100.
Time frame: 4 weeks
IL-1 Beta
Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Time frame: 4 weeks
IL-4
Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Time frame: 4 weeks
IL-6
Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Time frame: 4 weeks
IL-7
Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Time frame: 4 weeks
IL-8
Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4 weeks
IL-10
Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Time frame: 4 weeks
TNF Alpha
Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Time frame: 4 weeks
INF Gamma
Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Time frame: 4 weeks