Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of Cincinnati.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00885664
First Posted: April 22, 2009
Last Update Posted: May 15, 2009
Collaborators:
Abbott
Gilead Sciences
Information provided by:
University of Cincinnati
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Purpose
The purposes of this study are:
- To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects.
- To determine whether these side effects can be related to greater activation of the immune system.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Truvada (tenofovir/emitricitabine) Drug: Kaletra (lopinavir/ritonavir) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection |
Resource links provided by NLM:
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- 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. [ Time Frame: 24 weeks ]
Secondary Outcome Measures:
- To determine the relationship between 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 before and after the initiation of antiretroviral therapy. [ Time Frame: 24 weeks ]
| Enrollment: | 60 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Truvada |
Drug: Truvada (tenofovir/emitricitabine)
Tenofovir/emitricitabine fixed dose combination once daily
Other Name: Truvada
|
| Active Comparator: Kaletra |
Drug: Kaletra (lopinavir/ritonavir)
Lopinavir/ritonavir 400/100 mg twice daily
Other Name: Kaletra
|
Detailed Description:
- 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.
- 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.
- 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.
- To determine the relationship between adverse events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
- To determine the relationship between clinical events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Diagnosis of HIV infection.
- Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.
Exclusion Criteria:
- Blinded drug treatment.
- 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.
- Known resistance to proposed new HIV regimen or components of regimen.
- Requirement for drug therapy with known contraindication with proposed new antiretroviral therapy (see Prohibited and Precautionary Medications below)
- Pregnancy or breast feeding.
- 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.
- 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 Cockroft-Gault method is defined on page 33.
- 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.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885664
Locations
| United States, Ohio | |
| University of Cincinnati AIDS Clinical Trials Unit | |
| Cincinnati, Ohio, United States, 45267 | |
Sponsors and Collaborators
University of Cincinnati
Abbott
Gilead Sciences
Investigators
| Principal Investigator: | Carl J Fichtenbaum, MD | University of Cincinnati |
More Information
| Responsible Party: | Carl J. Fichtenbaum, MD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00885664 History of Changes |
| Other Study ID Numbers: |
IDC 30 |
| First Submitted: | April 20, 2009 |
| First Posted: | April 22, 2009 |
| Last Update Posted: | May 15, 2009 |
| Last Verified: | April 2009 |
Keywords provided by University of Cincinnati:
|
HIV immune reconstitution treatment naive |
Additional relevant MeSH terms:
|
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Lopinavir |
Tenofovir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |