Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive either an HIV vaccine or a placebo. Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo. Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo; 2) the time averaged area under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo.

Key facts

Study ID

NCT00080106

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

114

Starts

2004-06-01

Expected to finish

2011-05-01

Last updated by the study team

2021-11-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infected
• On a stable antiretroviral medication regimen (no changes to treatment within 4 weeks of study entry)
• Viral load less than 50 copies/ml
• Viral suppression for 2 years prior to study entry (documented viral loads less than 500 copies/ml)
• CD4 count of 500 cells/mm3 or greater
• Ad5 neutralizing antibody less than 200 units at screening
• Willing to stop antiretroviral medications for at least 16 weeks post-vaccination
• Hepatitis B surface antigen negative
• Weight more than 110 lbs
• Willing to use acceptable methods of contraception

You may not qualify if…

• Two consecutive viral loads of 500 copies/ml or greater at least 14 days apart during the 24 months prior to study entry
• Two consecutive CD4 counts less than 200 cells/mm3 before starting antiretroviral medications
• History of anaphylaxis
• Allergy to vaccine components
• History of cardiac, pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurologic disease which, in the opinion of the study official, will compromise study participation
• Pregnancy or breastfeeding
• Contraindication to intramuscular injection, such as anticoagulant therapy or thrombocytopenia
• Immune globulin or blood products within 3 months prior to study entry
• Live vaccine within 30 days prior to study entry
• Inactivated vaccine within 14 days prior to study entry
• Previous HIV vaccine
• History of an AIDS-defining illness. Patients with a history of Kaposi's sarcoma limited to the skin may participate.
• Currently taking drugs or other substances not approved by the FDA. Patients may be on antiretroviral agents not yet approved by the FDA as part of a clinical trial or through an expanded access program.
• Immunomodulatory agents (interferon, IL-2, GM-CSF, systemic corticosteroids, etc.) within 30 days prior to study entry
• Active alcohol or substance abuse which may interfere with the study

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Univ. of California Davis Med. Ctr., ACTU — Sacramento, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Washington U CRS — St Louis, Missouri, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Cornell CRS — New York, New York, United States
• AIDS Care CRS — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Pitt CRS — Pittsburgh, Pennsylvania, United States
• The Miriam Hosp. ACTG CRS — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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