Immune and Viral Outcomes of HIV-1 Therapy Interruption

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is safe and effective for enhancing the immune function of patients with HIV.

Key facts

Study ID

NCT00051818

Run by

The Wistar Institute

People needed

20

Starts

2000-09-01

Expected to finish

2003-07-01

Last updated by the study team

2016-02-09

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 positive
• HIV RNA < 500 copies/ml on a regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) and either one protease inhibitor (PI) or one nonnucleoside reverse transcriptase inhibitor (NNRTI) for 6 months prior to study entry - HIV RNA < 50 copies/ml at study screening
• CD4 > 400 cells/mm3 with CD4 nadir of > 100 cells/mm3
• Agree to Medication Event Monitoring System monitoring of one component of antiretroviral regimen
• HIV-1 viral load >10,000 copies/ml at any time prior to initiating the current uninterrupted HAART regimen
• Willing to abstain from all immunomodulatory drugs during the study

Where it is running

• The Wistar Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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