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Immunologic Deficiency Syndromes clinical trials

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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.

NCT ID: NCT00381524 Completed - Clinical trials for Human Immunodeficiency Virus

HIV Prevention in the Primary Care Setting

Start date: June 2004
Phase: N/A
Study type: Interventional

In the third decade of the HIV pandemic, what was once a uniformly and rapidly fatal disease has been transformed into a chronic illness by advances in the understanding of HIV pathogenesis and therapeutics. As a result, HIV-infected individuals are living longer and better lives. This phenomenon, coupled with a continued steady rate of new HIV infections in this country, has led to the highest U.S. HIV prevalence rates since the beginning of the epidemic. In the past, HIV prevention efforts were separate from routine primary care delivery due to multiple factors including stigma and time constraints. Recent events, including increases in sexually transmitted disease (STD) rates among HIV-infected persons and evidence that infected individuals can be super-infected by HIV strains resistant to antiretroviral therapy, have inspired the SPNS program initiative to develop demonstration projects for interventions to reduce risky sexual exposures among HIV-infected patients receiving primary care.

NCT ID: NCT00381212 Completed - Clinical trials for Acquired Immunodeficiency Syndrome

A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.

Start date: September 2006
Phase: Phase 1/Phase 2
Study type: Interventional

To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.

NCT ID: NCT00376012 Active, not recruiting - Tuberculosis Clinical Trials

Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis

Start date: February 2001
Phase: Phase 3
Study type: Interventional

Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens for the treatment of HIV-associated tuberculosis Phase: Phase III trial Population: 300 HIV positive patients with tuberculosis. Number of Sites:Four 1. Tuberculosis Research Centre, Chennai 2. Government General Hospital, Chennai 3. Government Hospital of Thoracic Medicine, Tambaram 4. Government Rajaji Hospital, Madurai Study Duration:36 months Study Objective:To study the efficacy of the standard RNTCP Category I regimen (2EHRZ3 / 4RH3) the control arm vs. an extended continuation phase regimen 2EHRZ3 / 7 RH3 in the treatment of pulmonary and extrapulmonary TB in the HIV positive patients. 2. To study the relationship between stage of HIV disease and response to anti-TB treatment. 3. To study recurrences and their nature (relapse/re-infection) in detail by using RFLP analysis. Study Design:It is a two armed prospective randomized open label controlled clinical trial with stratified random allocation based on CD4 count and sputum smear grade. All enrolled patients will be treated according to the RNTCP guidelines during the intensive phase. In the continuation phase, Cat I patients will be stratified by CD4 counts and by smear grade, and randomly allocated either to the standard RNTCP regimen, or to an alternative extended regimen (2EHRZ3/4RH3 or 2EHRZ3/7RH3).

NCT ID: NCT00370357 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

SPL7013 Gel - Male Tolerance Study

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

The purpose of this study is to determine if SPL7013 Gel (VivaGelâ„¢) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel, and the acceptability of the study products to the male volunteers.

NCT ID: NCT00363142 Completed - HIV Infection Clinical Trials

A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

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

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.