Status:
COMPLETED
Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Acute Infection and Early Disease Research Program
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 inf...
Detailed Description
While the advent of highly active antiretroviral therapy (HAART) has contributed to the increasing control of HIV infection and viral replication, ultimate control of HIV infection will require the de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00183261
Start Date
March 1 2006
End Date
October 1 2010
Last Update
November 1 2021
Active Locations (23)
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1
Ucsd Aiedrp
San Diego, California, United States, 92103
2
Ucsf Aiedrp
San Francisco, California, United States, 94110
3
LA Biomedical Research Institute at Harbor-UCLA AIEDRP
Torrance, California, United States
4
Univ. of Colorado Health Sciences Ctr. AIEDRP
Denver, Colorado, United States, 80220