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

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Interruption, HIV Therapeutic Vaccine, Acute Infection, Acute Retroviral Syndrome
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Ucsd Aiedrp
- Ucsf Aiedrp
- LA Biomedical Research Institute at Harbor-UCLA AIEDRP
- Univ. of Colorado Health Sciences Ctr. AIEDRP
- Fenway Community Health Ctr. CRS
- Washington U CRS
- Beth Israel Med. Ctr., ACTU
- Aaron Diamond AIDS Research Ctr. AIEDRP
- Unc Aids Crs
- UNC, Chapel Hill AIEDRP
- Duke Univ. Med. Ctr. Adult CRS
- Dumc Aiedrp
- The Miriam Hosp. ACTG CRS
- 407 Doctors CRS
- Holdsworth House Medical Practice CRS
- St. Vincent's Hospital CRS
- Taylor Square Private Clinic CRS
- AIDS Research Initiative, Darlinghurst CRS
- 407 Doctors (Australia) AIEDRP
- AIDS Research Initiative (Australia) AIEDRP
- St. Vincent's Hosp. (Australia) AIEDRP
- Taylor Square Private Clinic (Australia) AIEDRP
- Holdsworth House Gen. Practice (Australia) AIEDRP
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine at study entry and on Weeks 4 and 26
Participants will receive the MRKAd5 HIV-1 gag/pol/nef vaccine placebo at study entry and on Weeks 4 and 26