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Immunologic Deficiency Syndromes clinical trials

View clinical trials related to Immunologic Deficiency Syndromes.

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NCT ID: NCT00923364 Completed - MDS Clinical Trials

Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for MonoMAC

Start date: May 7, 2009
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00920426 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)

Start date: June 9, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood. It will also look at how people react to and how a human body uses GSK1265744. This study will compare the effects of GSK1265744 and placebo. The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will take part in Part 1 of the study receiving dose A. If additional dosing information is needed after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.

NCT ID: NCT00920296 Completed - Healthy Subjects Clinical Trials

DDI Study of Etravirine and GSK1265744

Start date: July 2009
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to compare steady-state plasma PK, safety and tolerability of GSK1265744 with and without etravirine

NCT ID: NCT00920088 Completed - Healthy Subjects Clinical Trials

Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs

Start date: June 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of GSK2448761 on CYP450 metabolic probes and to evaluate the 2-way interaction between GSK2448761 and two ritonavir-boosted protease inhibitors that are commonly used in HIV-infected subjects.

NCT ID: NCT00919854 Completed - Clinical trials for Human Immunodeficiency Virus 1

A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.

NCT ID: NCT00917904 Completed - Healthy Clinical Trials

An Expanded Safety Study of Dapivirine Gel 4789 in Africa

Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.

NCT ID: NCT00917891 Completed - HIV Infections Clinical Trials

An Expanded Safety Study of Dapivirine Gel 4759 in Africa

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.

NCT ID: NCT00914225 Completed - HIV Infections Clinical Trials

Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya

ITN
Start date: September 2009
Phase: N/A
Study type: Observational

In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and water-borne diseases such as malaria and diarrheal disease are common causes of illness and death. In addition, diarrhea and malaria are more common and more severe among adults and children infected with HIV. These infections may modulate the immune system, affect the replication of the HIV virus and could result in more rapid HIV disease progression in co-infected individuals. Access to practical, inexpensive and easy to use interventions to prevent these diseases may be effective in delaying HIV progression. Current Kenya government and World Health Organization guidelines recommend the use of cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and pathogens causing diarrhea remain common causes of morbidity and mortality in many resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria or other pathogens due to alternative mechanisms of action, antimicrobial resistance and non-compliance due to adverse events or other reasons. We propose a study to evaluate the impact of providing insecticide treated bednets and a simple water filtration device on markers of HIV disease progression among a cohort of ART naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate the effect of these interventions on malaria and diarrheal disease incidence and on compliance with TMP/SMX.

NCT ID: NCT00909129 Completed - Chronic Hepatitis C Clinical Trials

Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment

DICO
Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome.

NCT ID: NCT00908284 Completed - Clinical trials for Cardiovascular Diseases

Evaluating an Exercise Program to Reduce Cardiovascular Risk Factors in Children Infected With HIV

Start date: December 2008
Phase: N/A
Study type: Interventional

People infected with HIV are now living longer lives because of the use of highly active antiretroviral therapy (HAART). However, HAART medications have been shown to increase the risk of cardiovascular disease and metabolic dysfunction in adults. More research is needed on the effect of HAART in children. The purpose of this study is to assess cardiovascular risk factors in children infected with HIV who receive HAART medications and to determine the effectiveness of an exercise program on cardiovascular outcomes in these children.