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

NCT00885664 | Completed Phase 4 Results

• 1 other identifier: IDC 30
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are:

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

Conditions

HIV Infections

Keywords

HIV; immune reconstitution; treatment naive

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (10)

• SF-12 Physical Capacity Score

  4 weeks

• SF-12 Mental Capacity Score

  4 weeks

• IL-1 Beta

  4 weeks

• IL-4

  4 weeks

• IL-6

  4 weeks

Study Arms (2)

Truvada/Kaletra CD4<100

OTHER

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

Drug: Truvada (tenofovir/emtricitabine); Drug: Kaletra (lopinavir/ritonavir)

Truvada/Kaletra CD4>/=100

OTHER

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

Drug: Truvada (tenofovir/emtricitabine); Drug: Kaletra (lopinavir/ritonavir)

Interventions

Truvada (tenofovir/emtricitabine) DRUG

Tenofovir/emtricitabine fixed dose combination once daily

Also known as: Truvada

Truvada/Kaletra CD4<100; Truvada/Kaletra CD4>/=100

Kaletra (lopinavir/ritonavir) DRUG

Lopinavir/ritonavir 400/100 mg twice daily

Also known as: Kaletra

Truvada/Kaletra CD4<100; Truvada/Kaletra CD4>/=100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Diagnosis of HIV infection.
• Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.

You may not qualify if:

• 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 Cockcroft-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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Abbott: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

University of Cincinnati AIDS Clinical Trials Unit

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir; Emtricitabine; lopinavir-ritonavir drug combination; Lopinavir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Pyrimidinones; Thiazoles; Sulfur Compounds; Azoles

Limitations and Caveats

Small study of 60 subjects. Some subjects did not complete all study visits limiting data available for each time point.

Results Point of Contact

• Title: Dr. Carl J. Fichtenbaum
• Organization: University of Cincinnati

carl.fichtenbaum@uc.edu

513-584-6361

Study Officials

• Carl J Fichtenbaum, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants received truvada and kaletra in this trial

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: October 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 10, 2022
• Results First Posted: August 10, 2022

Record last verified: 2022-07

Locations

US (1)