Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women

Mayer, Kenneth H.; Karim, Salim Safurdeen. Abdool; Kelly, Clifton W.; Maslankowski, Lisa; Rees, Helen; Profy, Albert T.; Day, Jenny A.; Welch, Julie L.; Rosenberg, Zeda F.

doi:10.1097/00002030-200302140-00005

Cited by 93 publications

(76 citation statements)

References 18 publications

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“…Micronized CAP has shown to adsorb and inactivate HIV-1, HSV and other STIs (118). Earlier studies indicate that a gel formulation of micronized CAP has the potential to be used for topical intravaginal delivery of microbicides for prevention of STIs and HIV (119). It is converted into a gel and therefore does not have to be removed following its application (119).…”

Section: A Micronized Cellulose Acetate Phthalate Gel Formulationmentioning

confidence: 99%

“…Earlier studies indicate that a gel formulation of micronized CAP has the potential to be used for topical intravaginal delivery of microbicides for prevention of STIs and HIV (119). It is converted into a gel and therefore does not have to be removed following its application (119). CAP is one of the potential anti-HIV vaginal gel formulations that are under Phase II clinical trials (120).…”

Section: A Micronized Cellulose Acetate Phthalate Gel Formulationmentioning

confidence: 99%

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A Review of Current Intravaginal Drug Delivery Approaches Employed for the Prophylaxis of HIV/AIDS and Prevention of Sexually Transmitted Infections

et al. 2008

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Abstract. The objective of this review is to describe the current status of several intravaginal anti-HIV microbicidal delivery systems these delivery systems and microbicidal compounds in the context of their stage within clinical trials and their potential cervicovaginal defence successes. The global Human Immuno-Deficiency Virus (HIV) pandemic continues to spread at a rate of more than 15,000 new infections daily and sexually transmitted infections (STIs) can predispose people to acquiring HIV infection. Male-to-female transmission is eight times more likely to occur than female-to-male transmission due to the anatomical structure of the vagina as well as socio-economic factors and the disempowerment of women that renders them unable to refuse unsafe sexual practices in some communities. The increased incidence of HIV in women has identified the urgent need for efficacious and safe intravaginal delivery of anti-HIV agents that can be used and controlled by women. To meet this challenge, several intravaginal anti-HIV microbicidal delivery systems are in the process of been developed. The outcomes of three main categories are discussed in this review: namely, dual-function polymeric systems, non-polymeric systems and nanotechnology-based systems. These delivery systems include formulations that modify the genital environment (e.g. polyacrylic acid gels and lactobacillus gels), surfactants (e.g. sodium lauryl sulfate), polyanionic therapeutic polymers (e.g. carageenan and carbomer/lactic acid gels), proteins (e.g. cyanovirin-N, monoclonal antibodies and thromspondin-1 peptides), protease inhibitors and other molecules (e.g. dendrimer based-gels and the molecular condom). Intravaginal microbicide delivery systems are providing a new option for preventing the transmission of STIs and HIV.

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Section: A Micronized Cellulose Acetate Phthalate Gel Formulationmentioning

confidence: 99%

Section: A Micronized Cellulose Acetate Phthalate Gel Formulationmentioning

confidence: 99%

A Review of Current Intravaginal Drug Delivery Approaches Employed for the Prophylaxis of HIV/AIDS and Prevention of Sexually Transmitted Infections

et al. 2008

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“…Phase 1 trials of PRO-2000 microbicide gel have revealed its safety and acceptability in healthy women (Smita et al, 2006). PRO-2000 microbicide gel is also well tolerated by HIV-infected women and men (Mayer et al, 2003;Tabet et al, 2003). Unfortunately, PRO-2000 gel showed only modest protection among women against HIV-1 in a phase 2/2b study (Abdool Karim et al, 2011).…”

Section: Synthesized Peptides and Polymersmentioning

confidence: 99%

Closing the door to human immunodeficiency virus

2013

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The pandemic of human immunodeficiency virus type one (HIV-1), the major etiologic agent of acquired immunodeficiency disease (AIDS), has led to over 33 million people living with the virus, among which 18 million are women and children. Until now, there is neither an effective vaccine nor a therapeutic cure despite over 30 years of efforts. Although the Thai RV144 vaccine trial has demonstrated an efficacy of 31.2%, an effective vaccine will likely rely on a breakthrough discovery of immunogens to elicit broadly reactive neutralizing antibodies, which may take years to achieve. Therefore, there is an urgency of exploring other prophylactic strategies. Recently, antiretroviral treatment as prevention is an exciting area of progress in HIV-1 research. Although effective, the implementation of such strategy faces great financial, political and social challenges in heavily affected regions such as developing countries where drug resistant viruses have already been found with growing incidence. Activating latently infected cells for therapeutic cure is another area of challenge. Since it is greatly difficult to eradicate HIV-1 after the establishment of viral latency, it is necessary to investigate strategies that may close the door to HIV-1. Here, we review studies on non-vaccine strategies in targeting viral entry, which may have critical implications for HIV-1 prevention.

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“…These drugs encompass different mechanisms of action which require different drug targeting strategies for successful delivery (49)(50)(51)(52)(53)(54)(55). The mechanism of action of each microbicide agent will define the appropriate vaginal drug delivery system for those products.…”

Section: Microbicide Drug Candidatesmentioning

confidence: 99%

“…It has been demonstrated that PRO2000 is capable of protecting against HSV-2 in the mouse model (93), In these studies, the vaginal gel formulations used contained PRO 2000, Carbopol 1382, 0.05% lactic acid, and trolamine to adjust the pH to 4.5 (93). In a phase 1 study, the formulation was shown to be safe and tolerable to healthy volunteer women (94) and HIV-1 infected women (54). Although in a study comparing 2% and 4% formulations it was found that women exposed to the 4% gel product twice daily had more mild adverse events related to the genital tract than those women who were exposed to placebo or 2% formulation (54), PRO 2000 is currently being investigated in phase 2 and 3 clinical trials (95).…”

Section: Semisolids-hydrogelsmentioning

confidence: 99%

Vaginal Drug Delivery Systems for HIV Prevention

Rohan

Sassi

2009

AAPS J

140

130

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Abstract. Microbicides have become a principal focus for HIV prevention strategies. The successful design of drug delivery systems for vaginal microbicide drug candidates brings with it a multitude of challenges. It is imperative that the chemical and physical characteristics of the drug candidate and its mechanism of action be clearly understood and considered to successfully deliver and target drug candidates efficiently. In addition, an understanding of the dynamic nature of the vaginal environment, the tissue and innate barriers present, as well as patient preferences are critical considerations in the design of effective microbicide products. Although the majority of drug candidates clinically evaluated to date have been delivered using conventional semisolid aqueous-based gel dosage forms, drug delivery system design has recently been extended to include advanced delivery systems such as vaginal rings, quick-dissolve films, and tablets. Ultimately, it may be necessary to develop multiple dosage platforms for a single active agent to provide users with options that can be used within the constraints of their social environment, personal choice, and environmental conditions.

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Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women

Abstract: PRO 2000 Gel was safe and well tolerated in sexually active HIV-uninfected and sexually abstinent HIV-infected women, enabling the product to be considered for evaluation in efficacy trials.

Cited by 93 publications

References 18 publications

A Review of Current Intravaginal Drug Delivery Approaches Employed for the Prophylaxis of HIV/AIDS and Prevention of Sexually Transmitted Infections

A Review of Current Intravaginal Drug Delivery Approaches Employed for the Prophylaxis of HIV/AIDS and Prevention of Sexually Transmitted Infections

Closing the door to human immunodeficiency virus

Vaginal Drug Delivery Systems for HIV Prevention

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