Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
Completed · Phase 1
Conditions studied: HIV Infections
In brief
The aim of this trial is to find out if immune responses to HIV can be boosted in individuals who start medicines soon after being infected. If immune responses can be boosted to the virus, this may allow the body to control HIV without the need for medications. This study is designed to test a new strategy for boosting immune responses to HIV and to evaluate if these responses allow people to have control of HIV without medicines.
Key facts
- Study ID
- NCT00058734
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 5
- Starts
- 2000-11-01
- Last updated by the study team
- 2007-08-27
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Both HIV infected and HIV uninfected individuals are eligible for this study.
- CD4 cell count of 400 cells/mm3 or greater at study entry
- If HIV infected, initiated anti-HIV medicines within 120 days of infection
- If HIV infected, HIV viral load < 50 copies/ml for at least 3 months prior to study entry
- Current medication regimen for at least 3 months prior to study entry
- A particular blood type (HLA-A*0201)
- Acceptable methods of contraception
You may not qualify if…
- Received investigational drug or vaccine within 30 days prior to study entry
- On other immune-based therapy (e.g., interleukin-2, alpha interferon, immunoglobulin, thalidomide) within 30 days prior to study entry
- Megesterol acetate within 30 days prior to study entry
- Immunization within 4 weeks of study entry
- If hepatitis B virus (HBV) uninfected and at high risk for HBV infection, the patient will not be eligible until he or she has completed an HBV vaccine series.
- Unstable or severe medical condition, including active opportunistic infection requiring treatment
- History of Hashimoto's thyroiditis
- Cancer requiring chemotherapy within 6 months prior to study entry
- History of radiation therapy to axillary lymph nodes
- Significant laboratory abnormalities at study entry
- Pregnant or breastfeeding
- History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, scleroderma, mixed connective tissue disorder)
- Allergy to gentamicin, tobramycin, streptomycin, or amikacin
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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