Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef followed by treatment interruption can increase immune system function in adults with acute or recent HIV infection who have started taking anti-HIV drugs.

Key facts

Study ID

NCT00183261

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

25

Starts

2006-03-01

Expected to finish

2010-10-01

Last updated by the study team

2021-11-01

Who can join

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

You may qualify if…

• Initiated HAART within 30 days of an acute or recent HIV-1 infection diagnosis. More information on this criterion can be found in the protocol.
• Initiated HAART within 30 days of documented acute or recent HIV-1 infection without interruption for more than 7 days
• Sustained viral suppression, defined as a viral load of 500 copies/mL or less 12 months prior to baseline with an undetectable HIV-1 RNA viral load between 60 to 7 days prior to baseline
• CD4 count of 450 cells/mm3 or more OR 35% or more between 60 to 14 days prior to baseline
• Ad5 neutralizing antibody titer of 200 or less at screening
• Willing to follow all study procedures and schedules
• Willing to interrupt HAART for at least 24 weeks following completion of the vaccination stage
• Negative for hepatitis B surface antigen (HBsAg) at screening
• Willing to use acceptable forms of contraception
• Infected with HIV-1 subtype B, if this information is available

You may not qualify if…

• Virologic relapse, defined as 2 consecutive measurements of viral load of 500 copies/mL or more at least 7 days apart within 12 months of baseline visit
• Received more than 7 days of continuous HAART other than that received within 16 days of acute or recent HIV-1 infection. Participants who received HAART as part of post-exposure prophylaxis (PEP) more than 6 months prior to the start of initial HAART may be eligible, provided that they did not acquire HIV-1 infection from the event that required PEP.
• History of anaphylaxis or allergy to vaccine components, including Tris buffer, magnesium chloride, and polysorbate 80 (Tween)
• History of clinically significant heart, lung, kidney, liver, pancreatic, gastrointestinal, or neurological disease that, in the opinion of the study investigator, may interfere with the study
• Contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
• Receipt of any immune globulin or blood products within 3 months prior to baseline
• Receipt of any live vaccine within 30 days prior to baseline or any inactivated vaccine within 14 days prior to baseline
• Previous receipt of any HIV vaccine. Participants that were documented to have received only placebo are not excluded.
• History of any AIDS-defining illness. If a participant's sole AIDS-defining illness is Kaposi's sarcoma limited to the skin and is not anticipated to require systemic chemotherapy, that participant is not excluded.
• Currently receiving drugs or biologics not approved by the Food and Drug Administration (FDA) other than investigational HIV medications
• Current or past participation in other studies that might alter the participant's response to the study vaccination
• Use of any immunomodulatory agents, including but not limited to interleukin-2 (IL-2), granulocyte/macrophage-colony stimulating factor (GM-CSF), and systemic corticosteroids, within 30 days prior to baseline
• Active alcohol or substance use that, in the investigator's opinion, may interfere with the study
• Any other criteria or condition that, in the investigator's opinion, may interfere with the study
• Unwilling or unable to contribute to the planned peripheral blood mononuclear cell (PBMC) blood collection
• Pregnancy or breastfeeding

Where it is running

• Ucsd Aiedrp — San Diego, California, United States
• Ucsf Aiedrp — San Francisco, California, United States
• LA Biomedical Research Institute at Harbor-UCLA AIEDRP — Torrance, California, United States
• Univ. of Colorado Health Sciences Ctr. AIEDRP — Denver, Colorado, United States
• Fenway Community Health Ctr. CRS — Boston, Massachusetts, United States
• Washington U CRS — St Louis, Missouri, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• Aaron Diamond AIDS Research Ctr. AIEDRP — New York, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• UNC, Chapel Hill AIEDRP — Chapel Hill, North Carolina, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Dumc Aiedrp — Durham, North Carolina, United States
• The Miriam Hosp. ACTG CRS — Providence, Rhode Island, United States
• 407 Doctors CRS — Surry Hills, New South Wales, American Samoa
• Holdsworth House Medical Practice CRS — Darlinghurst, New South Wales, Australia
• St. Vincent's Hospital CRS — Darlinghurst, New South Wales, Australia
• Taylor Square Private Clinic CRS — Darlinghurst, New South Wales, Australia
• AIDS Research Initiative, Darlinghurst CRS — Darlinghurst, New South Wales, Australia
• 407 Doctors (Australia) AIEDRP — Sydney, Australia
• AIDS Research Initiative (Australia) AIEDRP — Sydney, Australia
• St. Vincent's Hosp. (Australia) AIEDRP — Sydney, Australia
• Taylor Square Private Clinic (Australia) AIEDRP — Sydney, Australia
• Holdsworth House Gen. Practice (Australia) AIEDRP — Sydney, Australia

Full record on ClinicalTrials.gov

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