Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection

Completed

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine whether patients who have asymptomatic HIV infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic, or immunologic consequences. This study will also assess the virologic, immunologic, and clinical outcomes in any patients who restart ART.

Key facts

Study ID

NCT00050284

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

158

Last updated by the study team

2010-11-09

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infection
• ART with 2 or more drugs for 6 or more months
• CD4+ cell count(s) > 350 cells/mm3 immediately prior to initiation of first ART
• CD4+ cell count > 350 cells/mm3 within 45 days prior to study entry
• Plasma viral load < 55,000 copies/ml within 45 days prior to study entry
• Willingness to discontinue ART at study entry
• Negative serum or urine pregnancy test within 14 days prior to study entry

You may not qualify if…

• Pregnancy or breast-feeding
• Systemic cancer chemotherapy, systemic investigational agents, or immunomodulators within 30 days prior to study entry
• Drug or alcohol use or dependence that would interfere with adherence to study requirements
• Illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or has been clinically stable on therapy for at least 30 days prior to study entry
• Chronic medical condition that would have a negative impact on the participation of the patient or would be expected to result in significant use of the medical care system
• History of an HIV-related illness or complication in CDC categories B and C
• Nonadherence to ART
• Active infection with hepatitis B and currently taking adefovir at doses > 10 mg or 3TC and/or TDF

Where it is running

• Univ of Southern California — Los Angeles, California, United States
• Univ of California, San Diego Antiviral Research Ctr — San Diego, California, United States
• Univ of California San Francisco — San Francisco, California, United States
• San Mateo County AIDS Program — Stanford, California, United States
• Santa Clara Valley Med Ctr — Stanford, California, United States
• Stanford Univ — Stanford, California, United States
• Willow Clinic — Stanford, California, United States
• Harbor General/UCLA — Torrance, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ — Chicago, Illinois, United States
• Cook County Hosp Core Ctr — Chicago, Illinois, United States
• Rush-Presbyterian / St.Lukes (Chicago) — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana — Indianapolis, Indiana, United States
• Wishard Hosp — Indianapolis, Indiana, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• St. Louis Connect Care — St Louis, Missouri, United States
• Washington Univ (St. Louis) — St Louis, Missouri, United States
• Beth Israel Med Ctr — New York, New York, United States
• NYU/Bellevue — New York, New York, United States
• Chelsea Clinic — New York, New York, United States
• The Cornell Clinical Trials Unit — New York, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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