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NCT03337542
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
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.
NCT01461096
Men who have sex with men (MSM) have an increased risk of developing anal human papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected women are also at risk of anal cancer. This study will evaluate the effectiveness of the Food and Drug Administration (FDA)-approved quadrivalent HPV vaccine, Gardasil, at preventing anal HPV infection in HIV-infected MSM and HIV-infected women.
NCT00096850
Rifampin (RIF) is used for the treatment of tuberculosis (TB), an infectious disease that affects many people with HIV. RIF was shown to lower concentrations and decrease the effectiveness of some anti-HIV drugs, including the HIV protease inhibitor (PI) atazanavir (ATV) boosted with ritonavir (RTV). The purpose of this study is to determine the interactions between RTV-boosted ATV and evaluate the safety and tolerability of giving these drugs together in HIV uninfected adults.
NCT00001024
Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to which antiretroviral therapy alters HIV replication in LT. Clinical objectives: To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures of HIV replication in PB and LT. To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response. One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.
NCT00000727
To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth, and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary HIV infection. AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate. The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone.
NCT00000844
To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals. Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
NCT00000651
To evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with zidovudine (AZT) versus AZT alone when administered to asymptomatic patients with a CD4 count = or \< 200 cells/mm3 and symptomatic patients with a CD4 count = or \< 300 cells/mm3. To compare the effectiveness of ddC alone and in combination with AZT versus AZT alone. ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly decrease mortality and reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. Because of the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted.
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.
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.
NCT02806947
The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.
NCT00001030
To compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex (MAC) bacteremia or disseminated MAC disease. To compare other parameters such as survival, toxicity, and quality of life among the three treatment arms. To obtain information on the incidence and clinical grade of targeted gynecologic conditions. Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment.
NCT00001133
In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look at any side effects that IDV or RTV causes. IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to work against HIV, it must be taken 3 times a day at a high dose and with a certain diet. Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose. This study will gather information about the safety and side effects of using IDV and RTV together.
NCT02965781
This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.
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.
NCT00000657
To compare the safety and effectiveness of orally administered didanosine (ddI) with high dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses of up to 1000 mg/day. HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.
NCT00458393
The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).
NCT02812771
Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.
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.