Publications by authors named "Beatrice Kallungal"
Article Synopsis
- AMD11070 is a compound that targets the CXCR4 receptor, showing promise in reducing HIV-1 levels in infected individuals.
- A phase IB/IIA study tested the drug's safety and antiviral effectiveness in HIV-infected participants, revealing that it was well-tolerated but had variable impact on reducing HIV RNA levels.
- Early termination of the study was necessary due to new findings of toxicity in animal tests, but some participants did experience a reduction in CXCR4-tropic virus levels, suggesting further exploration of similar therapies may be warranted.
Objective: To evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLSs).
Design: An open-label pilot study of LPV/r monotherapy in participants on first-line nonnucleoside reverse transcriptase inhibitor three-drug combination ART with plasma HIV-1 RNA 1000-200 000 copies/ml.
Methods: Participants were recruited from five sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network.
Background: The benefits of antiretroviral therapy during early human immunodeficiency virus type 1 (HIV-1) infection remain unproved.
Methods: A5217 study team randomized patients within 6 months of HIV-1 seroconversion to receive either 36 weeks of antiretrovirals (immediate treatment [IT]) or no treatment (deferred treatment [DT]). Patients were to start or restart antiretroviral therapy if they met predefined criteria.
Background: Controversy continues regarding the extent of ongoing viral replication in HIV-1-infected patients on effective antiretroviral therapy (ART). Adding an additional potent agent, such as raltegravir, to effective ART in patients with low-level residual viremia may reveal whether there is ongoing HIV-1 replication.
Methods: We previously reported the outcome of a randomized placebo-controlled study of raltegravir intensification in patients on ART with HIV-1 RNA <50 copies per milliliter that showed no effect on residual viremia measured by single copy assay.
Background: Most HIV-1-infected patients on effective antiretroviral therapy (ART) with plasma HIV-1 RNA levels below the detection limits of commercial assays have residual viremia measurable by more sensitive methods. We assessed whether adding raltegravir lowered the level of residual viremia in such patients.
Methods And Findings: Patients receiving ART who had plasma HIV-1 RNA levels below 50 copies/mL but detectable viremia by single copy assay (SCA) were randomized to add either raltegravir or placebo to their ART regimen for 12 weeks; patients then crossed-over to the other therapy for an additional 12 weeks while continuing pre-study ART.
Article Synopsis
- AMD070 is an oral medication that blocks the CXCR4 receptor and shows promise against a specific strain of HIV, tested on healthy male volunteers with varying dosages.
- The drug was generally well tolerated, with mild side effects like headaches and gastrointestinal issues, and demonstrated a dose-dependent increase in white blood cell count, indicating its activity in the body.
- Food intake significantly reduced the drug's effectiveness; however, the pharmacokinetics suggested that it was still active at the highest doses tested, reaching effective levels against HIV.
Subjects enrolled in studies are not always screened for routine habits such as smoking. Personal history is not always reliable and therefore an objective biomarker is necessary to screen for smokers. The objectives of this article were to review the metabolism of nicotine and other metabolic considerations associated with smoking; to review some of the routine methods used to assess exposure to nicotine-containing products; to revisit cotinine breakpoints utilized to distinguish smokers from non-smokers during screening for clinical trials; to assess the utility of screening questions regarding smoking practices; and to recommend standards for clinical pharmacology studies.
View Article and Find Full Text PDF