Conditions: HIV Infections
Keywords: HIV immune reconstitution treatment naive
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief 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.

Arms:
arm 1: All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4\<100 cells/cu mm arm 2: All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4\>/=100 cells/cu mm

Interventions: intervention 1: Truvada (tenofovir/emtricitabine) intervention 2: Kaletra (lopinavir/ritonavir)
Intervention descriptions: intervention 1: Tenofovir/emtricitabine fixed dose combination once daily intervention 2: Lopinavir/ritonavir 400/100 mg twice daily

Protocol document: