Active clinical trials for "HIV Infections"

To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a different safety profile than AZT. In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted.

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 administer colony-stimulating factor (GM-CSF) for 4 weeks to AIDS and advanced AIDS related complex (ARC) patients who have been receiving zidovudine (AZT) therapy, in order to obtain data on short-term effectiveness, safety, toxicity, pharmacokinetics, and tolerance of combined treatment with the two drugs. Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness. These individuals could, therefore, benefit from therapy with an effective antiretroviral agent. AZT, which is a powerful inhibitor of human retrovirus, has been approved for management of patients with symptomatic HIV infection. GM-CSF not only stimulates the bone marrow, it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro (test tube). Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection.

To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.

To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose related antiviral activity determined by quantitation of infectious HIV peripheral blood leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when present), CD4+ T-cells, and Beta-2- microglobulin. Recombinant soluble CD4 protein (rCD4) is a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4 binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction. Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date, Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to distinguish between these two products, a change in nomenclature has been made. In this protocol, whenever the original sequence CD4 molecule is referred to, it is called recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed generically, it is referred to as rsCD4.

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).

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with human immunodeficiency virus infection are at increased risk for developing osteoporosis. Identifying whether patients with human immunodeficiency virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with human immunodeficiency virus infection.

The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil (Londrina). This proposal will focus on the intervention development, pretesting, and feasibility testing. The primary outcome will be a 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.

A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.