Track topics on Twitter Track topics that are important to you
This post-marketing observational study is conducted for obtaining data on clinical, biological and virological outcomes, compliance and tolerability of using a Lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of naïve or experienced patients infected with HIV-1 in China.
Although LPV/r is frequently used world-wide, the evaluation of the outcomes, compliance and tolerance of anti-HIV strategies in the real life is still a major challenge in the management of HIV-infected patients who are on a life-long therapy, especially in China.
This study will help to develop effectiveness and safety profile of the Lopinavir/ritonavir containing regimen in Chinese HIV-1 infected patients, provide more choices of anti-HIV-1 strategies to Chinese experts and benefits Chinese HIV-1 infected patients.
It is planned to enroll approximately 100 patients in total. This will be a multicenter post-marketing observational study in China mainland.
Each patient will be observed during his/her Lopinavir/ritonavir - containing treatment regimen for a maximum period of 18 months.
If the physician decides to permanently discontinue Lopinavir/ritonavir before the end of the planned observational period of 18 months, the reason for the discontinuation and the new treatment regimen prescribed will be documented. The next routine follow-up visit will be the termination visit for this patient in this study.
This post-marketing observational study will be conducted in a prospective, single-arm, multicenter format.
As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 18 months period, which defines the survey for each patient. For indicative purpose, follow-up of patients should enable approximately 4 patient visits during this period. These visits will take place at average intervals of 6 months, apart from the first visit following inclusion (usually at the end of the first 3 treatment months) and apart from visits required because of intercurrent event. If treatment with Lopinavir/ritonavir is discontinued, standard practice is to review the patient after a period of 3 months.
For these reasons, the most likely visits are defined as "V1", "V2", "V3", "V4"although numbers and dates will depend only on the decision of the physician. As a result, failure to meet these suggested dates will not constitute a deviation of the protocol.
Time Perspective: Prospective
Site Reference ID/Investigator# 7244
Active, not recruiting
Published on BioPortfolio: 2014-07-23T21:10:00-0400
The main purpose of this protocol is to study the effect of an HIV medication, Kaletra (lopinavir/ritonavir), on buprenorphine in non-HIV infected people who have been receiving the same d...
The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) is the same among HIV-infected men compared with HIV-infected wome...
The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a comb...
The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-la...
This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred ...
The World Health Organization (WHO) recommends weight band dosing of antiretrovirals for children. Data are limited describing drug exposure/safety of lopinavir/ritonavir (LPV/r) using WHO weight-band...
The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment...
To assess HIV-1 post-exposure prophylaxis (PEP) non-completion at day 28, comparing ritonavir-boosted lopinavir versus cobicistat-boosted elvitegravir as a single-tablet regimen (STR), using tenofovir...
Combination antiretroviral therapy (cART) use in pregnancy has been associated with hormonal dysregulation. We performed a secondary retrospective analysis of longitudinal progesterone and estradiol l...
Sparing of antiretroviral drug classes could reduce the toxicity and cost of maintenance treatment for HIV infection.
An HIV protease inhibitor used in a fixed-dose combination with RITONAVIR. It is also an inhibitor of CYTOCHROME P-450 CYP3A.
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.
An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV.
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...
AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...