A randomized trial of the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with lipid abnormalities: AIDS Clinical Trials Group Study 5087.

There is a paucity of information on the safety and efficacy of lipid-lowering therapy for dyslipidemia associated with human immunodeficiency virus (HIV) and antiretroviral therapy. Our objective was to determine whether fenofibrate and pravastatin were equivalent for the treatment of combined dyslipidemia in HIV as measured by a composite of the National Cholesterol Education Project (NCEP) goals based on absolute values for low-density lipoprotein (LDL), triglycerides (TG), and high-density lipoprotein (HDL) and to compare the safety of these agents through 48 weeks. This was a randomized, open-label trial with subjects assigned to fenofibrate 200 mg (n = 88) or pravastatin 40 mg (n = 86) daily.

Undetectable plasma HIV RNA load predicts success after hepatitis B vaccination in HIV-infected persons.

Human immunodeficiency virus (HIV)-infected patients respond poorly to hepatitis B vaccination. Records of 194 HIV-infected patients were reviewed for factors associated with successful hepatitis B vaccination. Thirty-four patients (17.

Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers.

Background: Hypertension is an important modifiable cardiac risk factor in human immunodeficiency virus (HIV)-infected patients. Calcium channel blockers are substrates of cytochrome P450 3A and are commonly prescribed for hypertension. We evaluated potential bidirectional pharmacokinetic interactions between calcium channel blockers and coadministered indinavir and ritonavir.

Effect of efavirenz on the pharmacokinetics of simvastatin, atorvastatin, and pravastatin: results of AIDS Clinical Trials Group 5108 Study.

Efavirenz (EFV) is associated with hyperlipidemia when used in combination with other antiretroviral drugs. EFV is a mixed inducer/inhibitor of cytochrome P450 (CYP) 3A4 isozyme and may interact with hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors that are primarily metabolized via CYP3A4. To assess the drug-drug interaction of EFV used in combination with simvastatin (SIM), atorvastatin (ATR), or pravastatin (PRA), an open-label trial was conducted in 52 healthy adult HIV-seronegative subjects across AIDS Clinical Trials Group sites in the United States.

Cardiovascular and Endothelial Disease in HIV Infection.

As combination antiretroviral therapy improves outcome for HIV-infected patients, more focus is directed on the durability of these regimens and the prevention of long-term adverse events. Given the prevalence of metabolic complications associated with combination therapy, namely insulin resistance, dyslipidemia, and truncal adiposity, interest in whether these complications predispose patients to cardiovascular disease prematurely is appropriate. This paper reviews the most recent data regarding the effects of HIV and its treatment on endothelial dysfunction, serum biomarkers, and vascular indices, and provides an update on the risk for cardiovascular events in the HIV-infected patient population.

Maintained normalization of cardiovascular dysfunction 5 years after parathyroidectomy in primary hyperparathyroidism.

Background: Primary hyperparathyroidism (pHPT) has been associated with premature death in cardiovascular diseases. Short-term prospects for normalization of cardiovascular derangements have been described after parathyroidectomy. This study explores long-term effects of parathyroidectomy on cardiovascular functions in pHPT.

Phase I evaluation of the safety and pharmacokinetics of murine-derived anticryptococcal antibody 18B7 in subjects with treated cryptococcal meningitis.

A promising approach to improving outcomes in patients with cryptococcal meningitis is to use adjunctive passive immunotherapy with a monoclonal antibody (MAb) directed against the capsular polysaccharide of Cryptococcus neoformans. This is the first application of MAb therapy for the treatment of a fungal disease in humans. We determined the safety and maximum tolerated dose of the murine anticryptococcal MAb 18B7 in a phase I dose-escalation study.

Recombinant interferon- gamma 1b as adjunctive therapy for AIDS-related acute cryptococcal meningitis.

We conducted a phase 2, double-blind, placebo-controlled study to evaluate the safety and antifungal activity of adjuvant recombinant interferon (rIFN)- gamma 1b in patients with acquired immunodeficiency syndrome and acute cryptococcal meningitis. Patients received 100 or 200 microg of rIFN- gamma 1b or placebo, thrice weekly for 10 weeks, plus standard therapy with intravenous amphotericin B, with or without flucytosine, followed by therapy with fluconazole. End points included conversion of cerebrospinal fluid fungal cultures from positive to negative at 2 weeks, resolution of symptoms, and survival.

Safety of discontinuation of maintenance therapy for disseminated histoplasmosis after immunologic response to antiretroviral therapy.

We performed a prospective observational study to assess the safety of stopping maintenance therapy for disseminated histoplasmosis among human immunodeficiency virus infected patients after response to antiretroviral therapy. All subjects received at least 12 months of antifungal therapy and 6 months of antiretroviral therapy before entry. Negative results of fungal blood cultures, urine and serum Histoplasma antigen level of <4.

Discontinuation of maintenance therapy for cryptococcal meningitis in patients with AIDS treated with highly active antiretroviral therapy: an international observational study.

We conducted a retrospective, multicenter study evaluating the safety of discontinuing maintenance therapy for cryptococcal meningitis after immune reconstitution. Inclusion criteria were a previous definitive diagnosis of cryptococcal meningitis, a CD4 cell count of >100 cells/microL while receiving highly active antiretroviral therapy (HAART), and the subsequent discontinuation of maintenance therapy for cryptococcal meningitis. The primary end point was relapse of cryptococcal disease.

A comparison of the carbon balances of a natural lake (L. Orträsket) and a hydroelectric reservoir (L. Skinnmuddselet) in northern Sweden.

Carbon balances were calculated for the summer stratification period of 2001 for the hydroelectric reservoir L. Skinnmuddselet (created in 1989) and the natural L. Orträsket, and estimated on annual basis for both lakes.

Circadian cardiac autonomic nerve dysfunction in primary hyperparathyroidism improves after parathyroidectomy.

Background: Primary hyperparathyroidism has been associated with premature death in cardiovascular diseases, but reversibility and background mechanisms are uncertain. This study investigates autonomic nervous function in hyperparathyroidism because disturbances in this respect have been related to increased cardiovascular morbidity.

Methods: Twenty-one consecutive patients with hyperparathyroidism and 23 matched control subjects without interfering medication underwent electrocardiographic recordings and ambulatory blood pressure (ABP) determination during a 24-hour period.

Cardiovascular risk among HIV-positive patients on antiretroviral therapy.

Dyslipidemia is now recognized as a significant potential adverse event in HIV-positive patients who are on ART. The tide of evidence continues to flow between the shore of HIV being the primary factor behind increased cardiovascular risk in HIV-positive patients, and the ocean of HAART being the primary cause. However, there clearly is an association between long-term infection with HIV and metabolic abnormalities.

Short-term effects of cannabinoids in patients with HIV-1 infection: a randomized, placebo-controlled clinical trial.

Background: Cannabinoid use could potentially alter HIV RNA levels by two mechanisms: immune modulation or cannabinoid-protease inhibitor interactions (because both share cytochrome P-450 metabolic pathways).

Objective: To determine the short-term effects of smoked marijuana on the viral load in HIV-infected patients.

Design: Randomized, placebo-controlled, 21-day intervention trial.

Tolerance of efavirenz-induced central nervous system side effects in HIV-infected individuals with a history of substance abuse.

Purpose: There is no published data looking at tolerance of efavirenz (EFV) in patients who abuse cocaine or alcohol (EtOH). The objective of this study was to determine whether individuals with a current or past history of cocaine or EtOH abuse are more likely to experience EFV-induced central nervous system (CNS) side effects that warrant discontinuation of EFV compared with those who do not abuse substances.

Method: Retrospective chart review of all patients who received a nonnucleoside reverse transcriptase inhibitor (NNRTI) at an inner city Ryan White Title III-supported health clinic during 1992-2001.

Effect of simultaneous versus staggered dosing on pharmacokinetic interactions of protease inhibitors.

Objective: The aim of this study was to determine whether pharmacokinetic interactions between the protease inhibitors saquinavir soft gel, nelfinavir, and ritonavir are affected by the timing of administration.

Study Design: We used an open-label, 6-period, incomplete Latin square crossover study in 18 human immunodeficiency virus-negative subjects. Each received single oral doses of 2 of the 3 protease inhibitors during each of 6 periods.

A study of discontinuing maintenance therapy in human immunodeficiency virus-infected subjects with disseminated Mycobacterium avium complex: AIDS Clinical Trial Group 393 Study Team.

The present nonrandomized prospective study evaluated whether antimycobacterial therapy for disseminated Mycobacterium avium complex (MAC) could be withdrawn from human immunodeficiency virus-infected subjects who experienced immunologic recovery while receiving highly active antiretroviral therapy (HAART). Eligible subjects had received macrolide-based therapy for least 12 months, were asymptomatic for MAC, had received HAART for at least 16 weeks, and had CD4+ T cell counts >100 cells/microL. Forty-eight subjects were enrolled, with a median CD4+ T cell count of 240 cells/microL at the time of discontinuation of MAC therapy.

Nonnucleoside reverse transcriptase inhibitor resistance among antiretroviral-naive HIV-positive pregnant women.

From 1999 to 2001, the overall prevalence of resistance in the antiretroviral (ART)-naive population in St. Louis, Missouri, was 17%. We sought to determine if resistance testing in ART-naive HIV-positive pregnant women identified resistant mutations, which would modify our initial choice of therapy.

Tenofovir disoproxil fumarate therapy for chronic hepatitis B in human immunodeficiency virus/hepatitis B virus-coinfected individuals for whom interferon-alpha and lamivudine therapy have failed.

A significant proportion of human immunodeficiency virus (HIV) infected patients are coinfected with hepatitis B virus (HBV). Currently available treatments for chronic hepatitis B (interferon [IFN]-alpha and lamivudine [3TC]) have limited long-term utility because of side effects or of the development of resistance. Tenofovir disoproxil fumarate (TDF) is a nucleotide analog with excellent activity in vitro against HBV, which is also active against 3TC-resistant HBV variants.

Swedish forensic nursing care: nurses' professional contributions and educational needs.

Nurses (registered nurses, RN, and licensed mental nurses, LMN) working in five Swedish forensic psychiatric units filled in a questionnaire designed for general psychiatric nursing, but modified for forensic use. In this report, data regarding how nursing care could contribute to improved care and the organizational changes needed and what knowledge the nurses need, in order to be able to meet the demands in the future, were analysed by means of content analysis. The salient findings were: (i) an interpersonal patient-nurse relationship based on trust, empathy, respect and responsibility for the patients' personal resources and knowledge seems to be the essence of nursing care and a way to improve care; and (ii) the nurses' educational needs emanate from different treatment modalities, how to perform different treatments, how to establish developing relationships and in-service training adapted to the ward-specific problems.