Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs

Completed

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.

Key facts

Study ID

NCT00050063

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

78

Expected to finish

2004-05-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participation in A5058s and receipt of a minimum of 7 sets of injections on that study
• Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure
• No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry
• CD4+ T-cell count > 300 cells/mm3 obtained within 30 days prior to study entry
• HIV-1 RNA < 500 copies/ml obtained within 30 days prior to study entry
• Agreement to use approved methods of contraception

You may not qualify if…

• Pregnancy or breast-feeding
• Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery
• Symptomatic chronic infections other than HIV
• Malignancy that may require systemic therapy
• History of lymph node irradiation
• Use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed
• Hydroxyurea within 30 days prior to study entry
• Use of GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines within 30 days prior to study entry
• Active drug or alcohol use or dependence that would interfere with adherence to study requirements
• Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry

Where it is running

• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Case CRS — Cleveland, Ohio, United States
• Univ. of Texas Medical Branch, ACTU — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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