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

NCT00885664 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-10

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Truvada (tenofovir/emtricitabine)

Tenofovir/emtricitabine fixed dose combination once daily

DRUG

Kaletra (lopinavir/ritonavir)

Lopinavir/ritonavir 400/100 mg twice daily

Sponsors & Collaborators

Principal Investigators

  • Carl J Fichtenbaum, MD · University of Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00885664 on ClinicalTrials.gov