Efficacy and safety of twice-daily versus three-times daily saquinavir soft gelatin capsules as part of triple combination therapy for HIV-1 infection.
The objective of this study was to determine whether a triple therapy regimen incorporating twice-daily saquinavir is as effective as a three-times daily regimen. This was an open-label, Phase III, multicentre, 48-week study involving 837 HIV-1-infected patients...
Tenofovir disoproxil fumarate in nucleoside-resistant HIV-1 infection: a randomized trial.
Resistance to antiretroviral agents remains a leading cause of treatment failure for patients infected with HIV-1. To describe the efficacy and safety of tenofovir disoproxil fumarate (tenofovir DF) compared with placebo in patients with detectable viral replication...
Treating morphologic and metabolic complications in HIV-infected patients on antiretroviral therapy. A consensus statement of an advisory committee of the International Association of Physicians in AIDS Care.
OBJECTIVE: Clinicians are increasingly challenged by presentation of morphologic and metabolic complications in HIV-infected patients. These complications are associated with HIV infection and/or combination antiretroviral therapy. This Consensus Statement is intended...
The safety and tolerability of Z-100 in patients infected with HIV-1.
Z-100 is an extract of the Mycobacterium tuberculosis strain Aoyama B, which contains various polysaccharides. Aoyama B has previously been shown to induce a T helper 1-type cytokine response in various murine oncological models and has also demonstrated inhibitory...
A Pilot Study of Switch to Lopinavir/Ritonavir (LPV/r) Monotherapy from Nonnucleoside Reverse Transcriptase Inhibitor–Based Therapy
This study evaluated the safety and efficacy of switching HIV-infected patients with stable viral suppression on nonnucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) therapy to lopinavir/ritonavir (LPV/r) monotherapy....
Efficacy of the protease inhibitors tipranavir plus ritonavir in treatment-experienced patients: 24-week analysis from the RESIST-1 trial
Improved treatment options are needed for patients infected with multidrug-resistant human immunodeficiency virus type 1 (HIV-1). The nonpeptidic protease inhibitor tipranavir has demonstrated antiviral activity against many protease inhibitor-resistant HIV-1...
Efficacy and safety of three doses of tipranavir boosted with ritonavir in treatment-experienced HIV type-1 infected patients.
The efficacy, safety, and pharmacokinetics of three doses of tipranavir/ritonavir (TPV/r) in highly treatment-experienced human immunodeficiency virus (HIV)-1-infected patients with protease inhibitor (PI)-resistant isolates were evaluated. A 24-week multicenter,...
Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients
Agents for the treatment of HIV-1-infected patients with resistance to current antiretroviral (ART) drugs are needed. TMC114-C202 was a randomized, partially blinded, dose-finding study in treatment-experienced HIV-1-infected patients with one or more primary protease...
Pharmacokinetics, safety, and efficacy of tipranavir boosted with ritonavir alone or in combination with other boosted protease inhibitors as part of optimized combination antiretroviral therapy in highly treatment-experienced patients (BI Study 1182.51).
Given the limited treatment options for patients with high-level resistance, antiretroviral (ARV) regimens based on concomitant use of 2 ritonavir (RTV)-boosted protease inhibitors (PIs) were considered a therapeutic option. Boehringer Ingelheim (BI) study 1182.51...
Seven-year follow-up on lopinavir/ ritonavir monotherapy.
Previous studies of lopinavir/ritonavir (LPV/r) monotherapy have shown that over 70% of patients achieved HIV RNA levels <500 copies/mL over a follow-up period of 48 to 96 weeks, but the long-term durability is undetermined. Herein, the authors report 2 patients...
Progressive multifocal leukoencephalopathy in individuals with minimal or occult immunosuppression
Progressive multifocal leukoencephalopathy (PML) is a deadly demyelinating disease of the brain, caused by reactivation of the polyomavirus JC (JCV). PML has classically been described in individuals with profound cellular immunosuppression such as patients with AIDS,...
Utilization Patterns of Raltegravir within the OPERA Database
Background: Raltegravir (RAL) is a novel drug and first of the HIV integrase inhibitor class, gaining US market approval in October 2007. The current study evaluates the real world utilization patterns of RAL within the OPERA Clinical database. Methods: The analysis...
Injectable poly-L-lactic acid for human immunodeficiency virus-associated facial lipoatrophy: cumulative year 2 interim analysis of an open-label study (FACES).
Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians. To report cumulative year 2 interim study results examining the safety and efficacy of injectable PLLA in...
A randomized pilot study of tenofovir/emtricitabine (TDF/FTC) plus boosted atazanavir (ATV/r) vs. raltegravir (RAL BID) plus ATV/r vs. RAL BID plus ATV BID
Patients virologically suppressed on TDF/FTC + ATV/r may require alternative regimens that maintain suppression while addressing some drug-related side effects. We explored two alternative regimens that replace RTV and/or TDF/FTC. This open-label exploratory pilot...
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