Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Truvada (tenofovir/emtricitabine); Kaletra (lopinavir/ritonavir)
Intervention description: Tenofovir/emtricitabine fixed dose combination once daily; Lopinavir/ritonavir 400/100 mg twice daily
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants received truvada and kaletra in this trial
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; immune reconstitution; treatment naive

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age > 18 years

          2. Diagnosis of HIV infection.

          3. Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.

        Exclusion Criteria:

          1. Blinded drug treatment.

          2. Active untreated serious infection within 14 days of enrollment that in the opinion of
             the investigator would affect the subject's participation and/or safety in the study.

          3. Known resistance to proposed new HIV regimen or components of regimen.

          4. Requirement for drug therapy with known contraindication with proposed new
             antiretroviral therapy (see Prohibited and Precautionary Medications below)

          5. Pregnancy or breast feeding.

          6. Liver enzyme abnormalities on screening. Patients who have symptomatic Grade 3
             elevations of total bilirubin, AST, ALT, or alkaline phosphatase or Grade > 3
             elevations of total bilirubin, AST, ALT, or alkaline phosphatase will be excluded.
             Patients who have asymptomatic grade 3 elevations of total bilirubin, AST, ALT, or
             alkaline phosphatase may be included in the study at the discretion of the primary
             physician in consultation with the principal or senior investigator. Patients with
             grade 3 elevations of liver function tests who are co-infected with hepatitis B or
             hepatitis C may be included in the study at the discretion of the primary care
             physician in consultation with the primary or senior investigator provided that they
             do not have signs or symptoms of clinical hepatitis. Signs of clinical hepatitis
             include: icterus, abdominal tenderness and hepatosplenomegaly. Symptoms of clinical
             hepatitis include: fever, abdominal pain, anorexia, nausea, vomiting, fatigue,
             malaise, and myalgia.

          7. Decreased creatinine clearance at the time of screening. Patients with a creatinine
             clearance of <50mL/min as calculated by the Cockcroft-Gault method should be excluded
             from study entry. The Cockcroft-Gault method is defined on page 33.

          8. Other Grade ≥3 lab abnormalities. For any other laboratory abnormalities of grade 3 or
             higher, patients may be included or excluded from the study at the discretion of the
             primary care physician in consultation with the primary or senior investigator.