Status:
COMPLETED
Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 medica...
Detailed Description
Antiretroviral therapy (ART) has a significant impact on HIV disease; however, HIV cannot be cured with current drug regimens. While the majority of patients initially benefit from ART, drug regimens ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00080106
Start Date
June 1 2004
End Date
May 1 2011
Last Update
November 9 2021
Active Locations (28)
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1
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
2
Stanford CRS
Palo Alto, California, United States, 94304-5350
3
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States, 95817
4
Ucsd, Avrc Crs
San Diego, California, United States, 92103