Active clinical trials for "Immunologic Deficiency Syndromes"

To evaluate the safety, tolerance and efficacy of three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with AIDS and cryptococcal meningitis.

To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.

Background: Stem cells are immature blood cells that grow in the bone marrow and produce all of the cells needed for normal blood and immunity. Stem cells can be taken from one person (donor) and given to another person (recipient) through allogeneic stem cell transplantation. Donor stem cells can then replace the recipients stem cells in the bone marrow, restoring normal blood production and immunity. Most allogeneic transplants now use stem cells collected from the donors blood in a process called peripheral blood stem cell transplantation. Monocytopenia and mycobacterial infection (MonoMAC) is an immunodeficiency disease that is characterized by a lack of monocytes, a type of white blood cell, and an increased risk of developing mycobacteria infections that may cause tuberculosis. Allogeneic stem cell transplantation has been used successfully to treat many kinds of immune diseases and cancers that develop in blood or immune system cells. Researchers have been studying a particular kind of stem cell transplantation that uses lower than usual doses of chemotherapy and particular combinations of drugs to improve the results of the procedure for patients with blood-related cancers and pre-cancerous conditions. Objectives: To determine the safety and efficacy of reduced-intensity hematopoietic stem cell transplants (a particular stem cell transplantation procedure) for treating MonoMAC. Eligibility: Patients 18-60 years of age who have MonoMAC and who have been matched with a suitable stem cell donor. Design: Donors and recipients will undergo separate procedures as part of this protocol. Donors: National Institutes of Health researchers will take the donor s medical history, perform a physical exam, take blood samples, and explain the procedure. Tests will be performed to check the donors heart, lung, kidney, and liver function. Donors will receive injections of a drug called filgrastim (G-CSF), which causes stem cells to travel from bone marrow into blood. The G-CSF shots will be given for 5 to 7 days before the collection procedure. Donors will undergo apheresis to collect white blood cells and stem cells directly from the blood, which can be done as an outpatient procedure. Researchers may consider the alternative of directly collecting bone marrow from the donor, which will require an overnight hospital stay. Recipients: Recipients will receive 3 days of pre-transplant chemotherapy and radiation therapy to prepare for the transplant. For 4 days before the transplant, recipients will receive the chemotherapy drug fludarabine, followed by a single dose of radiation therapy, and will also receive the drugs tacrolimus and sirolimus to prevent the donor cells from attacking the recipient s normal tissues. Recipients will then receive the transplant of donor stem cells and will continue to receive tacrolimus and sirolimus for 3 months after the transplant to prevent the donor cells from attacking the recipient s normal tissues. Recipients will be discharged from the hospital once their condition is stable. Recipients will visit the NCI clinic regularly for the first 5 months after the transplant, and then less often for at least 5 years. Recipients may receive additional donor immune cells (donor lymphocyte infusion) after the transplant if the study doctors believe they are needed.

The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.

This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a suppressed HIV viral load on a Ritonavir (RTV) boosted Protease Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg BID.

Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons living in developing countries. Directly observed treatment, short-course (DOTS) is the internationally recommended strategy for the treatment of TB. However, the efficacy of DOTS for the treatment of HIV-associated TB is not well studied. This study aims to compare the efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

This phase II trial studies fludarabine phosphate and total-body irradiation with or without alemtuzumab followed by donor stem cell transplant to see how well it works in treating patients with immunodeficiency or other nonmalignant inherited disorders. Giving chemotherapy, such as fludarabine phosphate, a monoclonal antibody such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells.

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to investigate in subjects with detectable dual/mixed CCR5/CXCR4-tropic HIV whether vicriviroc when added to other appropriate HIV drugs can decrease the level of HIV (viral load) in the blood and that it is well tolerated. This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study of vicriviroc maleate in HIV subjects infected with dual/mixed CCR5/CXCR4-tropic virus and who have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI, NNRTI or PI) or at least 6 months experience with at least 2 of the following: one NRTI, one NNRTI, or one PI (excluding low-dose ritonavir) and failure on their current stable regimen. The study will compare the virologic benefit of adding vicriviroc to an optimized background regimen to a control group receiving placebo plus the new optimized background therapy. The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests performed at Screening, history of prior antiretroviral drug use by the patient, and drug toxicity. Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. An interim analysis will be performed when all subjects have completed 24 weeks of treatment. Subjects who complete 48 weeks of treatment, or who discontinue early but are deemed eligible upon rescreening, will be offered participation in the open-label segment of the study, and will receive vicriviroc 30 mg once daily, if appropriate, until commercially available or until the sponsor terminates the clinical development of vicriviroc.

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).