Active clinical trials for "AIDS-Related Complex"

AMENDED: 8/29/90 Inclusion of asymptomatic patients with CD4 counts less than 200 cells/mm3. Standardization of baseline evaluation schedule to allow 14 days prior to study dosing. Reduction in frequency and intensity of follow-up evaluations. Standardization of study endpoints. Inclusion of toxicity scoring and management for amylase and triglyceride elevations. Clarification of concomitant medication use. Original design: To determine the effectiveness of didanosine (ddI) in patients with AIDS or advanced AIDS related complex (ARC) who have documented hematologic intolerance to zidovudine (AZT) therapy. To determine if the efficacy of ddI increases with increasing doses. AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT. The major dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of 2 patients initially receiving 12 mg/kg/day and 12 patients receiving daily doses of 25.8 to 51.2 mg/kg; symptoms began 8 to 27 weeks after initiating ddI treatment. These neuropathy-like symptoms have generally not been associated with significant abnormalities in nerve conduction studies and patients have reported marked improvement in symptoms within 1 to 2 weeks of discontinuing ddI. Some patients have resumed ddI treatment at a reduced dose after resolution of their symptoms. Studies indicate that ddI remains active in the body for at least 12 hours. This indicates that benefits of ddI might be achieved with a low frequency of drug administration.

The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.

To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or advanced AIDS-related complex (ARC). Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.

To test the safety and tolerance of three different doses of recombinant human interleukin 2 (aldesleukin; IL-2), when it is given for five consecutive days to patients with AIDS or AIDS related complex (ARC), who have also received zidovudine (AZT) for at least 6 weeks just before beginning the IL-2 treatment. AZT is an antiviral drug, which has been shown to be beneficial in some patients with AIDS. IL-2 is a substance found naturally in the body that boosts the body's immune response to invading organisms and tumor cells. These two drugs, when administered together, may have a mutually helpful effect in treating AIDS patients, but before this effect can be studied, it is important to understand the proper dose and any side effects that may occur when these drugs are used together. The study will show how much AZT and IL-2 patients can safely take at the same time and how the two drugs will interact with each other.

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.

This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To assess pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).

To evaluate the safety, tolerance, and biological activity of filgrastim (recombinant granulocyte colony stimulating factor; G-CSF) given by daily subcutaneous injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe ARC. To evaluate the safety, tolerance, and biological activity of recombinant EPO given three times weekly by subcutaneous injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of three dose levels of AZT given concomitantly with G-CSF and EPO in patients with AIDS or severe ARC. To study the effects of G-CSF on neutrophil function and number in patients with AIDS or severe ARC. To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia, and semiquantitative HIV cocultures.

AMENDED: To provide ddC for patients with AIDS or advanced ARC who have failed treatment with, are intolerant to or are ineligible to receive zidovudine (AZT) and to demonstrate that ddC monotherapy is safe, and tolerable in this patient population. Original design: To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or advanced AIDS-related complex (ARC) who have failed treatment with or are intolerant to zidovudine (AZT) and who are also intolerant to dideoxyinosine (ddI); to demonstrate that ddC monotherapy is safe and tolerable in the treatment of patients who previously experienced either treatment failure, hematologic intolerance or myositis with AZT treatment and pancreatitis or other toxicities (except peripheral neuropathy with ddI).

To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.