PRO 2000

Last updated
PRO 2000
Clinical data
Other names2-Naphthalenesulfonic acid, sodium salt, polymer with formaldehyde
Identifiers
  • Sodium 2-naphthalenesulfonate, polymer with formaldehyde
CAS Number
ChemSpider
  • none
NIAID ChemDB
CompTox Dashboard (EPA)
ECHA InfoCard 100.111.201 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
Formula (C10H8O3S.CH2O.Na)x
Molar mass Approximately 5 kg/mol

PRO 2000 is an experimental vaginal microbicide which has been proposed as a preventive medicine for reducing the risk of contracting HIV. It has never been recommended as an effective medicine to be used for any purpose. Some clinical trials have shown that under some conditions it may provide some protection against HIV.

Contents

History

Endo Pharmaceuticals manufactures the drug. [1]

Efficacy

Animal testing studies done on macaques have shown that PRO 2000 is effective in preventing the transmission of HIV. Other studies have given supportive evidence that the product is safe in humans and would be an appropriate candidate for testing. [2]

A phase III clinical trial of 9385 women in sub-Saharan Africa showed that PRO 2000 was not effective in preventing transmission of HIV. [3]

Related Research Articles

<span class="mw-page-title-main">Zidovudine</span> Antiretroviral medication

Zidovudine (ZDV), also known as azidothymidine (AZT), is an antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use in combination with other antiretrovirals. It may be used to prevent mother-to-child spread during birth or after a needlestick injury or other potential exposure. It is sold both by itself and together as lamivudine/zidovudine and abacavir/lamivudine/zidovudine. It can be used by mouth or by slow injection into a vein.

The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multiple drugs that act on different viral targets is known as highly active antiretroviral therapy (HAART). HAART decreases the patient's total burden of HIV, maintains function of the immune system, and prevents opportunistic infections that often lead to death. HAART also prevents the transmission of HIV between serodiscordant same sex and opposite sex partners so long as the HIV-positive partner maintains an undetectable viral load.

Spermicide is a contraceptive substance that destroys sperm, inserted vaginally prior to intercourse to prevent pregnancy. As a contraceptive, spermicide may be used alone. However, the pregnancy rate experienced by couples using only spermicide is higher than that of couples using other methods. Usually, spermicides are combined with contraceptive barrier methods such as diaphragms, condoms, cervical caps, and sponges. Combined methods are believed to result in lower pregnancy rates than either method alone.

<span class="mw-page-title-main">Microbicides for sexually transmitted diseases</span> Pharmacologic agents and chemical substances

Microbicides for sexually transmitted diseases are pharmacologic agents and chemical substances that are capable of killing or destroying certain microorganisms that commonly cause human infection.

<span class="mw-page-title-main">Nevirapine</span> Chemical compound

Nevirapine (NVP), sold under the brand name Viramune among others, is a medication used to treat and prevent HIV/AIDS, specifically HIV-1. It is generally recommended for use with other antiretroviral medications. It may be used to prevent mother to child spread during birth but is not recommended following other exposures. It is taken by mouth.

<span class="mw-page-title-main">Pre-exposure prophylaxis</span> HIV prevention strategy using preventative medication for HIV-negative individuals

Pre-exposure prophylaxis (PrEP) is the use of medications to prevent the spread of disease in people who have not yet been exposed to a disease-causing agent, usually a virus. The term typically refers to the use of antiviral drugs as a strategy for the prevention of HIV/AIDS. PrEP is one of a number of HIV prevention strategies for people who are HIV negative but who have a higher risk of acquiring HIV, including sexually active adults at increased risk of contracting HIV, people who engage in intravenous drug use, and serodiscordant sexually active couples.

Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) co-infection is a multi-faceted, chronic condition that significantly impacts public health. According to the World Health Organization (WHO), 2 to 15% of those infected with HIV are also affected by HCV, increasing their risk of morbidity and mortality due to accelerated liver disease. The burden of co-infection is especially high in certain high-risk groups, such as intravenous drug users and men who have sex with men. These individuals who are HIV-positive are commonly co-infected with HCV due to shared routes of transmission including, but not limited to, exposure to HIV-positive blood, sexual intercourse, and passage of the Hepatitis C virus from mother to infant during childbirth.

Entry inhibitors, also known as fusion inhibitors, are a class of antiviral drugs that prevent a virus from entering a cell, for example, by blocking a receptor. Entry inhibitors are used to treat conditions such as HIV and hepatitis D.

Vedolizumab, sold under the brand name Entyvio, is a monoclonal antibody medication developed by Millennium Pharmaceuticals, Inc. for the treatment of ulcerative colitis and Crohn's disease. It binds to integrin α4β7. Blocking the α4β7 integrin results in gut-selective anti-inflammatory activity.

iPrEx

iPrEx was a phase III clinical trial to determine whether the antiretroviral medication emtricitabine/tenofovir could safely and effectively prevent HIV acquisition through sex in men who have sex with men and transgender women. iPrEx was the first human study of an HIV prevention strategy known as pre-exposure prophylaxis, or PrEP.

CAPRISA 004 is the name of a clinical trial conducted by CAPRISA. This particular study was the first to show that a topical gel could reduce a person's risk of contracting HIV. The gel used in the study contained a microbicide.

CONRAD is a non-profit organization scientific research organization that works to improve the reproductive health of women, especially in developing countries. CONRAD was established in 1986 under a cooperative agreement between Eastern Virginia Medical School (EVMS) and the United States Agency for International Development(USAID). CONRAD’s products are developed primarily for women in low-resource settings, in that they are designed to be safe, affordable and user-friendly. CONRAD is led by Scientific and Executive Director Gustavo Doncel, M.D., Ph.D. Primary funding for CONRAD comes from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID), with additional funding from The Bill & Melinda Gates Foundation and the National Institutes of Health (NIH).

HIV prevention refers to practices that aim to prevent the spread of the human immunodeficiency virus (HIV). HIV prevention practices may be undertaken by individuals to protect their own health and the health of those in their community, or may be instituted by governments and community-based organizations as public health policies.

A rectal microbicide is a microbicide for rectal use. Most commonly such a product would be a topical gel inserted into the anus so that it make act as protection against the contract of a sexually transmitted infection during anal sex.

A vaginal microbicide is a microbicide for vaginal use. Most commonly such a product would be a topical gel or cream inserted into the vagina so that it may treat some infection in the vagina, such as types of vaginitis.

BufferGel is the brand name of a spermicide and microbicide gel which is being tested for its potential development into a preventive medicine to stop the transmission of HIV.

<span class="mw-page-title-main">HIV/AIDS research</span> Field of immunology research

HIV/AIDS research includes all medical research that attempts to prevent, treat, or cure HIV/AIDS, as well as fundamental research about the nature of HIV as an infectious agent and AIDS as the disease caused by HIV.

HIV in pregnancy is the presence of an HIV/AIDS infection in a woman while she is pregnant. There is a risk of HIV transmission from mother to child in three primary situations: pregnancy, childbirth, and while breastfeeding. This topic is important because the risk of viral transmission can be significantly reduced with appropriate medical intervention, and without treatment HIV/AIDS can cause significant illness and death in both the mother and child. This is exemplified by data from The Centers for Disease Control (CDC): In the United States and Puerto Rico between the years of 2014–2017, where prenatal care is generally accessible, there were 10,257 infants in the United States and Puerto Rico who were exposed to a maternal HIV infection in utero who did not become infected and 244 exposed infants who did become infected.

Treatment as prevention (TasP) is a concept in public health that promotes treatment as a way to prevent and reduce the likelihood of HIV illness, death and transmission from an infected individual to others. Expanding access to earlier HIV diagnosis and treatment as a means to address the global epidemic by preventing illness, death and transmission was first proposed in 2000 by Garnett et al. The term is often used to talk about treating people that are currently living with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) to prevent illness, death and transmission. Although some experts narrow this to only include preventing infections, treatment prevents illnesses such as tuberculosis and has been shown to prevent death. The dual impact on well-being and its 100% effectiveness in reducing transmission makes TasP the most important element in the HIV prevention toolkit. In relation to HIV, antiretroviral therapy (ART) is a three or more drug combination therapy that is used to decrease the viral load, or the measured amount of virus, in an infected individual. Such medications are used as a preventative for infected individuals to not only spread the HIV virus to their negative partners but also improve their current health to increase their lifespans. Other names for ART include highly active antiretroviral therapy (HAART), combination antiretroviral therapy (cART), triple therapy and triple drug cocktail. When taken correctly, ART is able to diminish the presence of the HIV virus in the bodily fluids of an infected person to a level of undetectability. Undetectability ensures that infection does not necessarily have an effect on a person's general health, and that there is no longer a risk of passing along HIV to others. Consistent adherence to an ARV regimen, monitoring, and testing are essential for continued confirmed viral suppression. Treatment as prevention rose to great prominence in 2011, as part of the HPTN 052 study, which shed light on the benefits of early treatment for HIV positive individuals.

<span class="mw-page-title-main">Dapivirine Ring</span> Antiretroviral vaginal ring

Dapivirine (DPV) Ring is an antiretroviral vaginal ring pioneered by the International Partnership for Microbicides (IPM) pending for regulatory review. It is designed as a long-acting form of HIV prevention for at-risk women, particularly in developing nations such as sub-Saharan Africa. IPM has rights to both the medication and the medical device. A total of four rings with different drug diffusion systems and polymer composition have been developed by IPM. The latest design, Ring-004, is a silicone polymer matrix-type system capable of delivering DPV intravaginally in a sustained manner.

References

  1. "AIDSinfo - HIV/AIDS Drug Information - PRO 2000". aidsinfo.nih.gov. 2011. Archived from the original on October 17, 2011. Retrieved 20 November 2011.
  2. Patton DL, Cosgrove Sweeney YT, Paul KJ (October 2008). "A summary of preclinical topical microbicide vaginal safety and chlamydial efficacy evaluations in a pigtailed macaque model". Sexually Transmitted Diseases. 35 (10): 889–97. doi: 10.1097/OLQ.0b013e31817dfdb8 . PMID   18607310. S2CID   12260211.
  3. McCormack S, Ramjee G, Kamali A, Rees H, Crook AM, Gafos M, et al. (October 2010). "PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial". Lancet. 376 (9749): 1329–37. doi:10.1016/S0140-6736(10)61086-0. PMC   2956883 . PMID   20851460.