Abstract:
:In recent years, AIDS and sexually transmitted diseases (STDs) have become a burgeoning problem and are spreading at an alarming rate. Microbicides are being developed as a new therapeutic category for prevention of transmission of sexually transmitted infections (STIs) and HIV. Many of the microbicide formulations (MF) may fail to elicit a protective response either because of a lack of efficacy or inadequate formulation. Manufacturing a stable, efficacious, safe, and optimal product is the main objective of formulation development programs. Preformulation parameters (PP), as discussed in Part I of this series, influence formulation development significantly and should be considered carefully before designing a formulation strategy. Initially, based on PP and market research, a target product profile (TPP) is generated, which defines product attributes that can be normally classified as "essential" and "desirable." A complex and dynamic process begins thereafter that takes into consideration myriad factors starting from selection of delivery system, selection of excipients, compatibility study, prototype composition, selection of process and optimization, stability testing, scale up, manufacturing under good manufacturing practices (GMP), and packaging development. Prototype formulations are evaluated for several performance characteristics (e.g., dispersion behavior, bioadhesion, retention, spreading, rheology). These compositions are also subjected to biologic evaluation by various in vitro and in vivo models. Such a well-planned, well-coordinated, and well-implemented formulation development program not only accelerates overall development but also minimizes failures in subsequent clinical development studies. The objective of this review is to highlight the importance of formulation science, outline the steps involved in this process, and explore how these can be exploited for achieving optimal MF.
journal_name
AIDS Patient Care STDSjournal_title
AIDS patient care and STDsauthors
Garg S,Tambwekar KR,Vermani K,Kandarapu R,Garg A,Waller DP,Zaneveld LJdoi
10.1089/108729103322277402subject
Has Abstractpub_date
2003-08-01 00:00:00pages
377-99issue
8eissn
1087-2914issn
1557-7449journal_volume
17pub_type
杂志文章,评审abstract::The objectives of this research were to assess prevalence and predictors of early antiretroviral therapy adherence using multiple indicators and to estimate effects of early adherence on subsequent HIV viral load and CD4+ lymphocyte responses. Study subjects were adults with HIV infection referred to an antiretroviral...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/10872910252930867
更新日期:2002-04-01 00:00:00
abstract::Although the primary mode of hepatitis C virus (HCV) transmission is exposure to blood products or injection drug use (IDU), studies have found varying independent risk factors for HCV infection among persons with no history of IDU or exposure to blood products. For HIV-infected women, sexual transmission may be anoth...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2009.0111
更新日期:2009-11-01 00:00:00
abstract::Superior mesenteric artery (SMA) syndrome is a unique type of small bowel obstruction resulting from the compression of the duodenum by the SMA. This is a case of SMA syndrome in a cachectic 6-year-old boy with AIDS who presented after a 2.3-kg weight loss in the preceding month. Unfamiliarity with this condition coup...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/108729100318073
更新日期:2000-01-01 00:00:00
abstract::Little is known about the effectiveness of outreach interventions to engage and retain underserved populations living with HIV in stable, primary medical care. This study provided an opportunity to adapt a patient navigation model first developed for cancer care to assess its effectiveness with HIV-infected disadvanta...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2007.9987
更新日期:2007-01-01 00:00:00
abstract::Little is known about how people living with HIV in low prevalence contexts face the challenges of stigma and discrimination. Low prevalence and rural communities are unique environments in which HIV-related stigma and discrimination may be intensified due to lower tolerance of differences among people and greater fea...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2008.0168
更新日期:2009-04-01 00:00:00
abstract::Mood disorders are more frequent among people with HIV infection than among non-HIV-infected individuals of the same age, socioeconomic status, and HIV risks. They have been associated with worse adherence and clinical outcomes, yet remain underdiagnosed and undertreated in sub-Saharan Africa. We explored the relation...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2012.0089
更新日期:2012-10-01 00:00:00
abstract::Low 25-hydroxyvitamin D levels are common in the general and HIV-infected populations alike. Defined as levels less than 30 ng/mL, suboptimal vitamin D is known to afflict over 70% of representative samples from each group in resource-rich countries with even greater prevalence in resource-poor regions of the world. I...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章,评审
doi:10.1089/apc.2012.0145
更新日期:2012-09-01 00:00:00
abstract::Adolescents of parents infected with HIV/AIDS (HIV-affected adolescents) were recruited from August 1993 to March 1995 to examine their depression as a function of their social support. Adolescent depression and the size, frequency of contact, satisfaction, negative role model influence, and positive social support we...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2006.0066
更新日期:2007-06-01 00:00:00
abstract::Thrombotic thrombocytopenic purpura (TTP) is a rare but well-described complication of HIV infection, which occurs equally frequently during the early asymptomatic phase of HIV infection and with clinical AIDS. The clinical spectrum varies from a low-grade asymptomatic thrombocytopenia with mild renal insufficiency to...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.1996.10.349
更新日期:1996-12-01 00:00:00
abstract::Men who have sex with men (MSM) of color are disproportionately affected by HIV in the United States. Pre-exposure prophylaxis (PrEP) using antiretroviral medications is a newer biomedical prevention modality with established efficacy for reducing the risk of acquiring HIV. We conducted formative qualitative research ...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2016.0123
更新日期:2016-10-01 00:00:00
abstract::HIV infection is increasing in minority groups, particularly in African American and Hispanic women. Although the incidence of HIV dementia has decreased since the advent of highly active antiretroviral treatment, prevalence of neurocognitive complications has increased as patients are now living longer. This study's ...
journal_title:AIDS patient care and STDs
pub_type: 临床试验,杂志文章
doi:10.1089/apc.2006.0180
更新日期:2007-12-01 00:00:00
abstract::Imaging is often vital in the diagnosis and staging of acquired immune deficiency syndrome (AIDS) patients with regard to infections and malignancies. Non-Hodgkin's lymphoma is an AIDS-defining illness and a common AIDS-related malignancy. These lymphomas are usually high-grade immunoblastic, primary central nervous s...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/10872910260196422
更新日期:2002-08-01 00:00:00
abstract::Injection drug use (IDU) is an important vector of HIV infection in the United States. Many patients with HIV infection have comorbid substance use disorders. Integrated treatment for HIV and substance use disorders has been shown to improve HIV and other health outcomes, but significant barriers to integrated treatme...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2009.0242
更新日期:2010-01-01 00:00:00
abstract::We examined the relationships between survival after AIDS diagnosis and outpatient mental health service use among men with history of highly active antiretroviral therapy (HAART). Analysis involved 1913 black and 1684 white men with AIDS who received HIV care in 2003 in the Veterans Affairs health care system. Negati...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2009.0177
更新日期:2010-01-01 00:00:00
abstract::Among places where people living with HIV experience and anticipate HIV-related stigma, stigma in health care settings may be particularly harmful. Utilizing an exploratory sequential mixed methods approach, we conducted interviews (n = 76) and questionnaires (N = 460) with older adult women living with HIV enrolled i...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2018.0282
更新日期:2019-04-01 00:00:00
abstract::Although many methods for assessing adherence have been developed, most are not feasible for busy clinical settings. Using patients from the Adherence and Efficacy of Protease inhibitor Therapy (ADEPT) study (1998-2000), we systematically evaluated the relationship between psychosocial, environmental, clinical, and ot...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2006.20.760
更新日期:2006-11-01 00:00:00
abstract::The incidence of arterial and venous thrombosis in HIV-infected patients is increased compared to healthy controls. In this cross-sectional analysis we measured markers of endothelial cell activation, thrombin generation, fibrinolysis and anticoagulation combined with endogenous thrombin potential (ETP) and activated ...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2009.0173
更新日期:2009-12-01 00:00:00
abstract::We report a case of dual Mycobacterium tuberculosis (TB) and Pneumocystis jiroveci (carinii) (PCP) lymphadenitis in a patient with HIV who had been receiving trimethoprim-sulfamethoxazole (TMP-SMX) as systemic prophylaxis for PCP. This patient was successfully treated with antituberculosis medications and TMP-SMX. Our...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章,评审
doi:10.1089/apc.2006.20.1
更新日期:2006-01-01 00:00:00
abstract::T-20 is a novel antiretroviral agent that inhibits the fusion of human immunodeficiency virus (HIV) with target cell membranes. It is delivered by self-administered, twice-daily, subcutaneous injections. The impact of this mode of administration on patients' ability to conduct normal activities of daily living (ADL) a...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/108729102320231162
更新日期:2002-07-01 00:00:00
abstract::Acquired resistance to antiretroviral agents is an established sequela of HIV pharmacotherapy. Viral mutations can confer reduced susceptibility to antiretroviral medications, resulting in virologic and clinical failure in more than half of treated patients. Cross-resistance that can develop within each drug class lea...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章,评审
doi:10.1089/108729104323038874
更新日期:2004-04-01 00:00:00
abstract::Psoriasis occurs with at least undiminished frequency in HIV-infected individuals. The behavior of psoriasis in HIV disease is of interest, in terms of pathogenesis and therapy because of the background of profound immunodysregulation. It is paradoxical that, while drugs that target T lymphocytes are effective in psor...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章,评审
doi:10.1089/108729100317696
更新日期:2000-05-01 00:00:00
abstract::As the New York City HIV=AIDS epidemic began generalizing beyond traditionally high-risk groups in the early 1990s, AIDS Service Organizations (ASO) sought to increase access to medical care and broaden service offerings to incorporate the needs of low-income women and their families. Strategies to achieve entry into ...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2008.0056
更新日期:2009-01-01 00:00:00
abstract::Young men who have sex with men (MSM) represent an increasing number of new HIV infections in many communities. Many individuals still hold beliefs that may lead to discrimination against HIV-positive individuals. HIV stigma is associated with negative health and psychosocial outcomes and may lead to greater challenge...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2008.0256
更新日期:2009-05-01 00:00:00
abstract::We analyzed data from 1253 HIV-positive injection drug users (IDUs) entering detoxification or methadone maintenance treatment in New York City between 1990 and 2004 to assess HIV risk behaviors and their association with at-risk drinking (defined as more than 14 drinks per week for males or 7 drinks per week for fema...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2009.0027
更新日期:2009-08-01 00:00:00
abstract::HIV-seropositive, active injection-drug users (IDUs), compared with other HIV populations, continue to have low rates of highly active antiretroviral therapy (HAART) use, contributing to disparities in their HIV health outcomes. We sought to identify individual-level, interpersonal, and structural factors associated w...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2009.0240
更新日期:2010-07-01 00:00:00
abstract::Recommendations suggest that older children and adolescents perinatally infected with HIV (PHIV+) be informed of their HIV diagnosis; however, delayed disclosure is commonly reported. This study examined the prevalence and timing of HIV disclosure to PHIV+ adolescents and the associations between the timing of disclos...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2010.0161
更新日期:2011-04-01 00:00:00
abstract::In 2010, New York (NY) passed new legislation mandating Emergency Departments (EDs) to offer HIV tests to patients 13-64 presenting for care. We evaluated the requirement's implementation and determined differences based on HIV prevalence or site-specific designated AIDS centers (DACs). We also evaluated policies for ...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2013.0124
更新日期:2014-02-01 00:00:00
abstract::Uptake of HIV pre-exposure prophylaxis (PrEP) is low among women at risk for HIV acquisition. Of 468,000 women, whom the United States Centers for Disease Control and Prevention estimates to be eligible for PrEP, only 10,000 unique women have begun therapy through the third quarter of 2015. These data suggest insuffic...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2018.0030
更新日期:2018-12-01 00:00:00
abstract::Despite the advent of effective antiretroviral therapy (ART), HIV-seropositive injection drug users (IDU) continue to suffer from elevated levels of morbidity and mortality. Evidence is needed to identify social- and structural-level barriers to effective ART. We investigated the impact of homelessness on plasma HIV R...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2011.0169
更新日期:2012-01-01 00:00:00
abstract::We explored the relationship between vitamin D levels and insulin resistance (IR) among 1082 nondiabetic (754 HIV-infected) women enrolled in the Women's Interagency HIV study (WIHS), a large and well-established cohort of HIV infected and uninfected women in the US. Vitamin D levels 20-29 ng/mL were considered insuff...
journal_title:AIDS patient care and STDs
pub_type: 杂志文章
doi:10.1089/apc.2012.0400
更新日期:2013-06-01 00:00:00