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NCT00009555
The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men. Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.
NCT00006144
The purpose of this study is to better understand the relationship between age and HIV disease progression. This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.
NCT00006145
Cytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA for the treatment of CMV in the eye, is safe and effective in preventing CMV organ damage in people with HIV.
NCT00001061
To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers. Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
NCT00001067
To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time. Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
NCT00027339
Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options, selecting an effective anti-HIV drug combination is difficult. A combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy, may decrease viral load and increase drug activity. Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient. This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patient's response to anti-HIV therapy.
NCT00485264
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.
NCT00001104
Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the disease process in hemophilic patients who have HIV infection with no symptoms. The major clinical question is whether patients who receive chronic ZDV therapy will have a delay in the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of ZDV in hemophilic patients will also be studied. Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to his wife or other female sexual partner. To determine the effectiveness of counseling and education on the behaviors of the wives that place them at risk for HIV infection. To determine if antibodies to HIV either appear or disappear from the blood of any of the wives during the study. Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV. Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.
NCT00011011
Long-term control of HIV depends on improvement in an individual's immune system. The purpose of this study is to see if either stopping anti-HIV drugs for short periods of time and/or adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection. The study will test whether these treatment approaches are safe. The HIV vaccine in this study has been tested in people who did not have HIV infection and improved the way their immune system worked. This study will evaluate whether these same immune system changes happen in people with HIV, and, if such changes do occur, assess whether these changes help to improve control of HIV in these patients.
NCT00006066
The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children. IL-2 is an important substance produced by the body's white blood cells that helps the body fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection. It has not been studied very much in children and doctors need to know what doses are safe to give.
NCT00001009
To determine the effectiveness and safety of dextran sulfate (DS) as a treatment for patients with AIDS, AIDS related complex (ARC), or asymptomatic HIV infection with or without persistent generalized lymphadenopathy (PGL), and to determine antiviral activity at different doses of DS. Although zidovudine (AZT) has shown promise in prolonging life in patients with AIDS and severe ARC, it has significant blood toxicities. It would be beneficial to combine AZT with another antiviral agent that does not have the same toxicity. DS might be a suitable drug since it has shown antiviral activity against HIV in the laboratory, and in preliminary studies it has shown little toxicity. Also, the combination of DS with AZT has been shown to be more effective than either alone.
NCT01310413
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.
NCT03480763
This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.
NCT00084058
The purpose of this study is to determine the effect of increased doses of lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing their current antiretroviral regimen
NCT00033163
Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to 3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials; tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be examined.
NCT00008463
The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare the 2 regimens to see which has fewer side effects. HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.
NCT00001015
To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood. RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC).
NCT00001136
The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune system responds to this vaccine. Vaccines are given to people to try to resist infection or prevent disease. There are a number of different HIV vaccines that are currently being tested. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the immune system responds to it.
NCT00421174
The study is designed as a Phase III, multi-center randomized, double-blind, placebo-controlled trial investigating the use of etanercept for the treatment of acute, non-infectious pulmonary dysfunction (IPS) occurring after allogeneic hematopoietic cell transplantation (HCT).
NCT00001116
The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can lower the amount of IL-6 in HIV-positive patients. This study will also examine the effect of TNFR:Fc on TNF-alpha. IL-6 and TNF-alpha are 2 substances produced by the immune system that may increase the rate of HIV replication. IL-6 and TNF-alpha are produced naturally by the body. High levels of TNF-alpha lead to increased IL-6 production and increased HIV replication, therefore helping the virus infect the body. HIV-positive patients who receive IL-2 (interleukin-2, a protein that helps the immune system fight infection) tend to have higher levels of IL-6 and TNF-alpha than patients not receiving IL-2. These increased levels may contribute to some of the flu-like symptoms related to IL-2 administration. TNFR:Fc can neutralize TNF-alpha to decrease the action of TNF-alpha and, in turn, decrease the amount of IL-6 in the body. TNFR:Fc may, therefore, have a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2 administration.