Active clinical trials for "Immunologic Deficiency Syndromes"

To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.

To determine the following about the use of SC-48334 in patients with AIDS and advanced AIDS related complex (ARC): 1. The largest maximum tolerated dose (MTD); 2. Effectiveness against HIV; 3. Pharmacokinetics - how fast SC-48334 reaches the bloodstream, what concentration is reached, and how long it remains in the patient's blood. SC-48334 is a chemical that prevents the biochemical actions of certain enzymes in the body, and recent studies have shown that it may also prevent the activity of HIV. The study will attempt to show whether SC-48334 can safely and effectively break the cycle of HIV infection in AIDS and advanced ARC by progressively eliminating HIV.

To determine whether administration of human recombinant erythropoietin (REPO) improved or eliminated the anemia seen in human immunodeficiency virus (HIV) infected patients after therapy with zidovudine (ZDV).

To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum effective dose required for reliable engraftment for subjects undergoing hematopoietic stem cell transplantation for non-malignant disease.

The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).

This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.

HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin [RIF]) are an important component of TB therapy because of their unique activity. The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to reduced concentrations of these agents with risk of treatment failure or resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that their co-administration can be used safely and effectively. However, the side effect profile of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG concentrations similar to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment option for TB-infected patients who require concurrent treatment for HIV infection. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be supplied with DTG until it is locally approved and commercially available, the subject no longer derives clinical benefit, or the subject meets a protocol-defined reason for discontinuation, which ever comes first.

This study was designed to determine a dose of weekly subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%) that produces steady-state AUC of total IgG that was non-inferior to that of the regularly administered intravenous dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency subjects. This study was also designed to determine steady state trough total IgG levels after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety and tolerability of IGSC 20%.