Vaccination of HIV-1 Infected Patients With Dendritic Cells in Addition to Antiretroviral Treatment - (DALIA Trial)

Completed · Phase 1

Conditions studied: HIV

In brief

The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients.

Key facts

Study ID

NCT00796770

Run by

Baylor Research Institute

People needed

19

Starts

2008-11-01

Expected to finish

2011-09-01

Last updated by the study team

2017-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years old
• written informed consent
• HIV1 infection documented by any licensed ELISA test kit and confirmed by Western Blot at anytime prior to study entry
• on treatment with a combination of antiviral drugs (HAART) for at least 12 months, and stable on treatment for at least 3 months prior to enrollment. HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral drugs (other than 3 Nucs only and low dose ritonavir used for boosting other protease inhibitors does not count as one of these three antiretroviral agents)
• CD4+ T cell counts > 500 cells/mm3 on at least two consecutive measurements (including the screening value) within the previous 6 months prior to enrollment (occasional CD4 cell counts ranging between 450-500 cells/mm3 is permitted)
• nadir CD4+ T cell counts > 300 cells/mm3 prior HAART
• plasma HIV-RNA ≤ 50 copies/mL on at least two consecutive measurements (including the screening value) within the previous 3 months prior to enrollment (occasional so called 'blips' up to 200 copies/mL are permitted)
• no history of CDC class C event (Appendix 2)
• no vaccination in the last 3 months
• blood cells and chemistry:
• neutrophils ≥ 1,000/mm3
• platelets ≥ 100,000/mm3
• hemoglobin ≥ 10 g/dl
• creatinin ≤ 1.5 x N
• ASAT, ALAT, conjugated bilirubin ≤ 2.5 x N
• Adequate Kidney Function proteinuria ≤ 1 g/l (++)by urinalysis

You may not qualify if…

• Nadir CD4+ T cell counts < 300 cells/mm3 prior HAART
• pregnant or lactating woman
• any prior chemotherapy treatment
• interferon alpha (IFN-α-2b) or sargramostim (GM-CSF) < 12 weeks before the beginning of the trial
• interleukin-2 (IL-2) <12 weeks before the beginning of the trial,
• corticosteroids or other immunosuppressive agents <12 weeks before beginning the trial
• active asthma and/or on treatment for asthma,
• any history of malignancy (except basal carcinoma of the skin) including any hematologic malignancy or AIDS defining malignancy, such as lymphoproliferative disorder or Kaposi's sarcoma. Patients with Kaposi's sarcoma limited to the skin that disappeared while on HAART therapy, and without requiring any other systemic therapy, 1 year prior to study entry will be eligible to participate
• angina pectoris or with congestive heart failure, with auto-immune disease, or evolutive pulmonary disease, or organ failure
• active infections including viral hepatitis
• history of thrombocytopenia
• chronic hepatitis B or C
• previous exposure to any HIV experimental vaccine.

Where it is running

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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