NIAID HIV and Emerging Infectious Diseases Program

FMEX Study

Study name

HIV Expression in Patients with Viral Loads Suppressed on Highly Active Antiretroviral Therapy (HAART)

Study number

02-I-0232

Goal of Study

The NIH is conducting a research study to measure HIV in men and women who have very low viral loads (<50 copies RNA/mL) using an experimental viral load assay.

Study Regimen

During the study, participants will intensify their current HIV treatment regimen by adding another medication. We will perform frequent blood sampling and viral load measurements. The study will last approximately four months. The additional study medication will be provided, as well as the HAART regimen, for 30 days. Volunteers will be compensated.

Eligibility Criteria

• You are age 18 or older with documented HIV infection
• Your viral load is <50 and your CD4 is >200
• You are on a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (“non-nuke” or NNRTI) but NOT both
• You are willing to take an additional HIV medication for 30 days
• You have not had IL-2 within the past four months
• You are not pregnant
• You have not had an illness or fever three weeks prior to study enrollment
• You do not have HIV drug resistance
• You cannot be intolerant to either Kaletra® (lopinavir/ritonavir) or Sustiva® (efavirenz)

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