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Immunologic Deficiency Syndromes clinical trials

View clinical trials related to Immunologic Deficiency Syndromes.

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NCT ID: NCT00434070 Completed - Clinical trials for Acquired Immunodeficiency Syndrome

Relationship of Viral Resistance Development to CD4 Monitoring Alone or With Viral Load Monitoring

Start date: February 7, 2007
Phase:
Study type: Observational

This study will examine whether HIV-infected patients are more likely to develop resistance to antiretroviral therapy if their blood is not monitored for the number of viruses (viral load) in the body. A virus that changes (mutates) over time may become resistant to certain types of medicine. This resistance may affect future treatment options. This study will compare the amount of virus in the blood of HIV-infected patients who have been monitored for viral load with the amount of virus in the blood of patients who have not been monitored for viral load. For patients who have detectable virus, the type of resistance (mutations) of the virus will be determined by comparing the components of the virus with that of a virus that is known not to be resistant. HIV-infected patients 18 years of age or older who are being treated at the Infectious Diseases Institute at Mulago Hospital at Makerere University in Kampala, Uganda, may be eligible for this study. Participants are interviewed about the treatments they have received for HIV and how they usually take their anti-HIV drugs. They also have a blood sample drawn for research tests.

NCT ID: NCT00431548 Completed - HIV Infections Clinical Trials

Retinal Oxygen Reactivity in Patients Infected With Human Immunodeficiency Virus (HIV)

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

Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several hypotheses including infectious damage of the retinal vasculature and altered retinal hemodynamics have been postulated. The latter would be compatible with the theory that the retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the retina is not possible and indirect methods have to be employed. The study objective was to investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with HIV.

NCT ID: NCT00426517 Completed - Clinical trials for Inherited Immune Deficiencies

Donor Stem Cell Transplantation for Congenital Immunodeficiencies

Start date: January 19, 2007
Phase: Early Phase 1
Study type: Interventional

This study uses transplantation to treat patients with problems in their immune system. The immune system cells come from the bone marrow where they grow from special cells called stem cells. Giving patients stem cells from someone else may help to cure many patients with certain immune diseases. This is called 'bone marrow transplantation'. This procedure can have side effects that are life-threatening. To try to make transplantation safer we are using lower doses of the medications used in preparing the patient for the transplant. 'Conditioning' treatments are given to patients to create space in their bone marrow. This lets the cells of the donor go into the bone marrow and produce normal immune cells. This study will use lower doses of a drug called busulfan and lower doses of radiation than what are currently being used in other kinds of bone marrow transplantation for other diseases. Another problem that can occur with bone marrow transplantation is 'graft-versus-host disease'. This happens when the cells of the donor attacks different parts of the patient s body. This study will use a medicine called sirolimus instead of the usual medicine, cyclosporine, to prevent graft-versus-host disease. To go onto this study, you must have: 1. A severe immune deficiency, such as chronic granulomatous disease or leukocyte adhesion deficiency. 2. Have problems from the disease that call for stem cell transplantation. 3. You must also be between the ages of 2 and 40 years. Two groups of patients are included in this study: 1. Patients who have a brother or sister that have stem cells that match the patient. This is known as an allogeneic matched sibling transplant. 2. Patients who do not have a matched sibling donor but have a donor that matches in the National Marrow Donor Program. This is know as matched unrelated donor transplantation. Patients will have the following procedures: - To create space in the bone marrow, patients are given two drugs, Campath-1H and busulfan. To prevent the body from getting rid of the donated cells, patients are given sirolimus. On the day before the BMT, patients in the matched unrelated donor group also receive a low-dose of whole-body radiation. This will further improve the chances that the patients body will accept the donor cells. - Patients will get the donor stem cells through an intravenous (IV) line that goes into a vein in their body. The cells make their way to the bone marrow space and slowly refill the marrow over the next several weeks. Patients will usually stay in the hospital for 30 days after the transplant. - For the first 3 months after the transplant, patients are watched closely. The patients will have frequent visits to the clinic. During these visits the patient will have a physical examination and blood tests. The doctor and nurse will also check any symptoms the patient may have. At day 100 after the transplant a sample of bone marrow is taken. - Patients will continue to be followed periodically for at least 5 years after the transplant.

NCT ID: NCT00419341 Completed - Clinical trials for Primary Immune Deficiency

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

Start date: November 2006
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT00405184 Completed - Clinical trials for Primary Immune Deficiency (PID)

Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)

Start date: May 2007
Phase: Phase 3
Study type: Interventional

This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.

NCT ID: NCT00398125 Completed - HIV-1 Infection Clinical Trials

Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults

Start date: November 2006
Phase: Phase 2
Study type: Interventional

To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults

NCT ID: NCT00394004 Completed - HIV Infections Clinical Trials

Decision-Making of Hispanics and African-Americans With HIV/AIDS Participating in Clinical Trials

Start date: October 26, 2006
Phase: N/A
Study type: Observational

This study will use focus groups and in-depth individual interviews to explore factors that influence the decision of Hispanics and African-Americans with HIV/AIDS to participate in a research study. HIV-positive Hispanic and African-American patients 18 years of age and older who are enrolled in an NIH HIV/AIDS protocol may be eligible for Part 1, Part 2, or both parts of this study, as follows: Part 1 - Focus group Focus group participants of from six to ten people are interviewed together during a one-time, 2-hour tape-recorded session to explore how they arrived at their decision to enroll in a research study. The group discussion is led by a moderator and a facilitator. Before the session begins, participants complete questionnaires that include information about their age, race, ethnicity, education and social support. Hispanic participants also complete a questionnaire about language preference. At the end of the focus group, participants are offered to be interviewed individually, as described below. Part 2 - In-depth interview An investigator conducts a one-on-one in-depth interview with the participant while a second person observes and tape records the interview. The interview may take from 1 1/2 to 2 hours to complete. Participants who were not in a focus group are asked to complete questionnaires as described in Part 1 above.

NCT ID: NCT00391131 Completed - Clinical trials for Primary Immunodeficiency (PID)

Subcutaneous Ig NextGen 16% in PID Patients

Start date: April 2007
Phase: Phase 3
Study type: Interventional

This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using predominately chromatographic techniques. Eligible patients will switch from monthly intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial hospital training will be required for subcutaneous administration and then the patient will perform the infusion in their own home, returning once a month for a supervised infusion. Patients will be monitored on the study for up to 10 months to assess blood IgG levels and rate of serious bacterial infections.

NCT ID: NCT00389324 Completed - Clinical trials for Immunologic Deficiency Syndrome

A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

Start date: November 2006
Phase: Phase 2
Study type: Interventional

This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.

NCT ID: NCT00386347 Completed - HIV Infection Clinical Trials

A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.

Start date: October 2006
Phase: Phase 1
Study type: Interventional

This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.