View clinical trials related to HIV Seropositivity.
Filter by:This study will examine abnormalities in mitochondria (energy-producing machinery of cells) and in genes related to mitochondria in the blood cells, muscle, and fat of HIV-positive patients who are taking nucleoside reverse transcriptase inhibitors (NRTIs) and in patients not currently taking HIV medications, and compare the results to healthy volunteers. Many patients with HIV infection take NRTIs to help control the infection. These medications may damage cell mitochondria, possibly causing side effects such as fatigue. This study will explore the relationship between changes in mitochondria and related genes and patient reports of energy level, mood and quality of life. Healthy volunteers and HIV-infected patients between 18 and 55 years of age may be eligible for this study. Healthy volunteers must test negative for the HIV antibody. HIV-positive patients must have been diagnosed positive for at least 1 year. Patients who are taking antiretroviral therapy must have been taking the same drug regimen (with at least two NTRIs and no protease inhibitors) for at least 3 months. HIV positive patients not taking antiretroviral medication must not have had antiretroviral therapy for at least 1 year. Candidates are screened with a medical history, brief physical examination, blood and urine tests, and questionnaires related to mood and energy. Qualified volunteers will undergo the following procedures during three or four study visits: Visit 1 Complete history and physical examination, blood tests, and questionnaires about energy level, mood, and quality of life. Visit 2 Muscle and fat biopsy: Before the biopsy, blood is drawn to check blood counts and to test for pregnancy in women who can become pregnant. The biopsy is done on an outpatient basis in the operating room. The site of the biopsy (an area on the upper arm or upper leg) is numbed with an injection under the skin. A 1-inch incision is made over the muscle to be biopsied and a small sample of muscle tissue and small sample of fat are removed. The incision is then closed and bandaged. Following the biopsy, you will be monitored for about 4 hours in the clinic. Strenuous physical activity should be restricted in the week following biopsy to allow healing. Visit 3 Examination of biopsy site and possible apheresis: The biopsy site is examined for healing. Apheresis may be scheduled for this visit or for an extra visit between the biopsy and the final visit. This procedure for obtaining white blood cells for study is optional. For apheresis, blood is withdrawn from a needle placed in a vein in the arm and the white cells are separated from the rest of the blood. The white cells are extracted and the red cells and plasma are then returned to the body through a second needle.
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.
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.
Background: Kaposi s sarcoma (KS) is caused by a gammaherpesvirus called Kaposi s sarcoma-associated herpesvirus (KSHV), or human herpesvirus-8 (HHV-8). However, infection with KSHV is not sufficient to cause KS, and HIV infection is an important cofactor. Treatment of HIV with potent antiretroviral therapy can reduce the risk of KS, and can also induce regression in patients with established HIV-KS. One mechanism by which HIV is believed to contribute to KS is through HIV-induced immunodeficiency which leads to a loss of immunologic control of KSHV and/or KS itself. However, other mechanisms may also contribute. Objectives: One primary objective is to assess the effects of the initiation of potent anti-HIV therapy on specific factors possibly linked to the control or pathogenesis of KS, namely serum viral IL-6 and plasma VEGF levels, in patients with KS or at risk for KS by virtue of being infected with KSHV/HHV-8. Another is to assess the effects of anti-HIV therapy on KSHV infection. Secondary objectives are to assess the effects of potent antiretroviral therapy on established KS and other factors related to KS or KSHV infection. Eligibility: The principal eligibility factors are age 13 or above, HIV infection, and either KS or infection with KSHV. Exclusion factors include KS that requires specific therapy, recent corticosteroid therapy, recent cytokine therapy, or opportunistic infections requiring therapy. Design: Patients will be treated with potent antiretroviral therapy. For patients with established KS, the effects of the therapy on the KS will be monitored. In addition, a variety of factors related to KS, HIV infection, therapy, or KSHV infection will be monitored. These include the HIV viral load, KSHV secretion in saliva, the CD4 count, serum VEGF levels, and serum IL-6 levels.
To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of Proleukin on the time to progression of CMV retinitis in patients being treated with therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.
This study is designed as a randomized, open trial of intermittent continuous infusions of Interleukin-2 in HIV seropositive patients with a CD4 cell count between 200 and 500 cells/mm(3). The goal of the study is to determine the optimal duration of each infusion, and the optimal interval between infusions. Thirty-six patients will be randomized to 3 groups: Group A will be the control group with a regimen of five day infusions of IL-2 every eight weeks; Group B will receive IL-2 infusions every eight weeks, however the duration of each infusion will be determined by parameters reflecting T cell proliferation, with discontinuation of each infusion at a point when the response appears to be maximized; Group C will receive five day infusions of IL-2; however the interval between infusions will be determined by the response seen to the prior infusion, with the goal of administering infusions while the CD4 cell count remains above baseline from the prior infusion. The dose of interleukin-2 to be used will be 9 MIU by continuous infusion daily. All patients will be evaluated at the NIH at least every 4 weeks, and at that time safety labs and immune studies will be performed. In addition, patients in Groups B and C will undergo a laboratory evaluation weekly, at which time immune parameters, including CD4 number and percent, spontaneous blast transformation, soluble IL-2 receptor levels, and viral parameters, including branched DNA assay and p24 antigen, will be determined. The study duration will be approximately one year.
To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic parameters with toxicity. To investigate antiviral activity of the combined regimen. Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).
To determine the safety of intravenous infusion of ampligen in symptomatic HIV-infected patients at several dose levels, to determine the maximum dose that can be tolerated, and to measure the effects of ampligen on the HIV virus infection, immune function, and clinical condition. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that can be achieved without noticeable harmful side effects.