HIV/AIDS Clinical Trials
Last Reviewed: August 25, 2017
What is a clinical trial?
A clinical trial is a research study done to evaluate new medical approaches in people. New approaches can include:
- new medicines or new combinations of medicines
- new surgical procedures or devices
- new ways to use an existing medicine or device
Clinical trials are the fastest way to determine whether new medical approaches are safe and effective in people.
What is an HIV/AIDS clinical trial?
HIV/AIDS clinical trials help researchers find better ways to prevent, detect, or treat HIV/AIDS. All the medicines used to treat HIV/AIDS in the United States were first studied in clinical trials.
Examples of HIV/AIDS clinical trials under way include:
- studies of new medicines to treat HIV
- studies of vaccines to prevent or treat HIV
- studies of medicines to treat infections related to HIV
Can anyone participate in an HIV/AIDS clinical trial?
It depends on the study. Some HIV/AIDS clinical trials enroll only people who have HIV. Other studies include people who don’t have HIV.
Other factors such as age, gender, HIV treatment history, or other medical conditions may also restrict who can participate in an HIV/AIDS clinical trial.
What are the benefits of participating in an HIV/AIDS clinical trial?
Participating in an HIV/AIDS clinical trial can provide benefits. For example, many people participate in HIV/AIDS clinical trials because they want to contribute to HIV/AIDS research. They may have HIV or know someone who has HIV.
People with HIV who participate in an HIV/AIDS clinical trial may benefit from new HIV medicines before they are widely available. HIV medicines being studied in clinical trials are called investigational drugs. To learn more, read the AIDSinfoWhat is an Investigational HIV Drug? fact sheet.
Participants in clinical trials can receive regular and careful medical care from a research team that includes doctors and other health professionals. Often the medicines and medical care are free of charge.
Sometimes people get paid for participating in a clinical trial. For example, they may receive money or a gift card. They may be reimbursed for the cost of meals or transportation.
Are HIV/AIDS clinical trials safe?
Researchers try to make HIV/AIDS clinical trials as safe as possible. However, volunteering to participate in a study that is testing an experimental treatment for HIV can involve risks of varying degrees. Risks can include unpleasant, serious, or even life-threatening side effects from the treatment being studied.
In a process called informed consent, study volunteers are informed of the possible risks and benefits of a clinical trial. Understanding the risks and benefits helps volunteers decide whether to participate in the study.
If I decide to participate in an HIV/AIDS clinical trial, will my personal information be shared?
The privacy of study volunteers is important to everyone involved in an HIV/AIDS clinical trial. The informed consent process includes an explanation of how a study volunteer’s personal information is protected.
How can I find an HIV/AIDS trial in which to participate?
To find an HIV/AIDS clinical trial looking for volunteers, use the AIDSinfo clinical trial search. For help with your search, call an AIDSinfo health information specialist at 1-800-448-0440 or email ContactUs@aidsinfo.nih.gov.
This fact sheet is based on information from the following sources:
- HIV/AIDS clinical trials are research studies that look at new ways to prevent, detect, or treat HIV/AIDS. Clinical trials are the fastest way to determine if new medical approaches to HIV/AIDS are safe and effective in people.
- Examples of HIV/AIDS clinical trials under way include studies of new HIV medicines, studies of vaccines to prevent or treat HIV, and studies of medicines to treat infections related to HIV.
- The benefits and possible risks of participating in an HIV/AIDS clinical trial are explained to study volunteers before they decide whether to participate in a study.
- Use the AIDSinfo clinical trial search to find HIV/AIDS studies looking for volunteer participants. Some HIV/AIDS clinical trials enroll only people who have HIV. Other studies enroll people who don’t have HIV.
- Call 1-800-448-0440
- (1 p.m. to 4 p.m. ET)
- Send us an email
Twenty years ago, the subject of HIV (human immunodeficiency virus), which has been found to be the cause of AIDS (acquired immunodeficiency syndrome), would not have been the topic of a major and serious worldwide catastrophe. Twenty years ago, people were not phased by the effects that would be caused by this ever so populating disease, and no one would have ever realized that this disease would not be curable or helped without expensive medicine. Like a simple exponential growth equation, the AIDS virus has increased victim numbers by about forty million all over the world.
AIDS has also shown that it is not discriminating; it has infected all races and all heritages. The AIDS crisis extends far beyond its death toll, because more than seventy percent of the thirty-six million people with HIV/AIDS live in sub-Saharan Africa. Last year alone, the disease killed 1.5 million people in Africa. One third of these victims are between the ages of ten and twenty-four. The disease has been described as a development crisis; it is profoundly disrupting the economic and social bases of families and entire nations at a rate of infection at 16,000 per day.
Without immediate action, AIDS will surpass the effect of the Black Plague that killed forty million people in the late fourteenth century. It is estimated that only ten percent of the death that this disease will cause has been seen. There are no known cures or affordable vaccines to prevent AIDS; the only option is for a program to prevent further spread of the epidemic, minimize its impact, and provide care and nurture for those affected. The truth is, however, that not all nations have the capability or resources of preventing such catastrophes from happening; interventions must be placed in order for the country of Africa to have this problem diminished. They cannot to do this alone. AIDS is at war with Africa, and in any war, support is needed from allies. Without much needed assistance, Africa may lose this war against not only its people, but also its economy, which could lead to political downfall.
Lessons from history make the problem of the AIDS epidemic more comprehensive. People of different sectors of the world have already relayed to experiences of past epidemics. The rise of the Black Plague, smallpox, cholera, typhoid or typhus, and influenza among a few others, has taught the world of the great threat of infectious diseases. Although these diseases are known to occur, it still remains alarming when that initial threat begins to rise and rise until opportunities to fight against the disease becomes limited. AIDS has reached that point where if immediate action is not administered then chances of stopping the spreading infection will become extinct as will many lives along the road too.
One of the first epidemics of time, the bubonic plague which was also paraphrased as the Black Death, began in 1346. Wiping out more than one-third of the total population in Europe, the Black Death caused blotches or boils on the body that were spread from the bite of a parasitic flea living on the black rat. While the Black Death was the first of these types of catastrophic epidemics, it was not the last. Cholera was a world wide epidemic that infected large parts of the world over seven different periods of time. Cholera is transmitted through infected water and manifests itself as an acute infection of the gastrointestinal tract. With specific reference to the cholera epidemic, one author writes:
Whenever cholera threatened European countries, it quickened social apprehensions. Wherever it appeared, it tested the efficiency and resilience of local administrative structures. It exposed relentlessly political, social, and moral shortcomings. It prompted rumors, suspicions, and, at times, violent social conflicts.
There is no question that an epidemic in these proportions would disrupt the economic and social aspects of a nation, but without a doubt the political economy of the nation would be disrupted. The AIDS crisis is at the point where the disease is destroying any hope for the country of Africa to develop into a prospering state. The origin of AIDS in Africa remains unknown. In one theory it is believed that the disease originated in Haiti and was transported to Africa in the mid 1960s when a large number of Haitians immigrated to Zaire. In another prominent theory, however, it is believed that AIDS originated in Africa by means of a virus similar to HIV found in the African green monkey. According to this theory, the precursor virus may have moved from subhuman primates to people relatively recently, or it may have been present in a few resistant carriers from previously isolated tribes for a long time and was just recently transmitted to the cities by migration. There is evidence to support and dispute both theories, however, and it remains uncertain exactly when or how AIDS began in Africa. Although many theories also exist as to where AIDS began in Africa, most evidence points to the theory that it began somewhere in the region of East Central sub-Saharan Africa. Many sources also agree that AIDS probably began closer to the Great Lakes Region since the countries that contain or border these lakes are the countries in which the largest numbers of AIDS patients have been documented to date. From here, people infected with the HIV virus may have migrated into larger towns and cities located along major highway and waterway transportation routes. It is also believed that truck drivers and city prostitutes, who often migrate from city to city, have played a large role in the spread of the disease. Over time, the prominent social factors in some of the culture systems of sub-Saharan Africa, the pressure for high fertility and high reproductive rates, has caused many sub-Saharan African’s sexual attitude to evolve into one which finds it necessary to have an large number of sexual partners. This increased number of partners has lead to the tolerance of high levels of promiscuity, mainly commercialized forms. The possible transmission of the HIV virus increases with every new sexual act and new sexual partner. With this attitude, many assume that sub-Saharan Africans cannot help the fact that their likelihood of acquiring the disease is heightened. Frequenting prostitutes is another possible way in which sub-Saharan Africans increase their likelihood of acquiring the disease. Prostitution, being one of the most frequented forms of commercialized sex, makes it possible for a sexual encounter almost anywhere in sub-Saharan Africa and the possibility of passing any disease, including the HIV virus to someone from the opposite end of the continent. This attitude held by sub-Saharan Africans causes an increased number of sexual partners, causes tolerance for promiscuity and prostitution and increases the likelihood of transmission of the HIV virus. Programs need to be developed in which education is provided about the risks of these diseases.
One of the main reasons that the AIDS problem remains unresolved in sub-Saharan Africa is the numerous different cultural traditions and behaviors that exist toward sex. The cultures of this region are extremely diverse and include a wide variety of traditions dealing with sexual relationships, circumcision, and tribal healing methods that contribute to the spread of AIDS. In one Zambian culture, for example, it is tradition that a woman have sex with all of her husband’s male relatives when he dies. In another culture, young men are encouraged to have sexual relations with a number of eligible women during the time between puberty and marriage. In such cultural practices as these, there is little support for change to safer sex behaviors. Young people in Africa are growing up with the mind states of their predecessors, and the need for education on relationships, marriage, and safe sex needs to be addressed. Programs and interventions must be placed to better enable the people of Africa to understand the risk of their behaviors. One of the constant problems of battling AIDS in sub- Saharan Africa is the people it targets. In sub-Sarahan Africa homosexuality, IV drug use, and blood transfusions are not the highest risk of contracting HIV, but unprotected heterosexual intercourse spreads the virus more quickly. In turn making men, women, and children all equally suspectible to infection. Children are born knowing that there life span has been cut in half, and they accept the fact. While many around the world are getting the most developed treatments that are being discovered, people of Africa are only receiving generic drugs because of the high cost to the production of the best medicines. AZT, one of the newer AIDS drugs that prolongs life, costs between $500 to $1000 a month. While South Africa had previously passed a law that would allow it to make cheap, generic versions of these types of drugs, but drug companies worldwide took South Africa to court in a lawsuit saying that patents were being violated, profits were tumbling, and expensive research was being stifled. Moreover, after already being sued for use of just the generic drug, most people of Africa had not received the correct dosage or systematic observation for the medicine, which could result in the evolution to HIV resistance to drugs that may be administered in the future. Drugs must be available readily for the people of Africa in their fight against the growing rate of deaths. More money must be provided for prevention and health care.
Along with the financial, educational, and cultural changes needed to rid Africa of AIDS, government assistance is required to help organize the needs of its people. The epidemic’s greatest impact is likely to be felt by individuals living with HIV/AIDS, the health sector, and the poorest households. Governments can play an important role in mitigating these impacts, especially by prohibiting discrimination against HIV-infected persons in health care settings and in the workforce and by strengthening anti-poverty policies, but the most important lesson for governments to learn is that it is imperative to prevent the impacts of AIDS in the first place, through vigorous, effective interventions aimed at changing the behavior of those most likely to contract and spread infection. Today’s leaders can decide whether their children will grow up in a world where one out of four potential marriage partners is infected with a fatal sexually transmitted disease and AIDS patients occupy half of all hospital beds, leaving fewer beds for other patients. Prompt action today can prevent these impacts or help to reverse them.
The U.S. involvement in the AIDS crisis in Africa has one goal alone and this is to reduce the human suffering and death of this epidemic. The issue of ethics comes into play when dealing with the fate of Africa. Is the U.S. going to allow the unnecessary death of millions of Africans when there are other people of other races getting the treatment needed just because their country can afford the “luxury?” Does the U.S. concern focus on money versus the life of an innocent child? More spending needs to be directed toward the African government, while interventions are placed on the education of human rights and disease control.
The AIDS epidemic, it’s been said, is no more an African problem than the Holocaust was a European problem. The challenge it poses to the West is moral. The proper response is dictated not only by self-interest, but also by selflessness. So say all the world’s great teachers, and every good heart: When people suffer, they must be soothed. Those who have much must give to those who have little.
Policy Option A
The first option may be to let the African government control their own epidemic, and to stay out of the issue at hand. This option would be devasting to the reduction of AIDS epidemic because the government in Africa can not possible afford the resources that it would take to rebuild a community without this disease. Without help from an outside source, the destructive pattern of the disease would continue to grow at an exponential rate until spreading rapidly throughout the entire nation and disrupting any type of political or global state.
Policy Option B
Another option would be to join forces with the Global Fund, and to only use these resources as the main source of financial support. Using this money may enable the production of cheap drugs or programs made to teach Africans the danger of unsafe intercourse and condom use. However the Global Fund program only has $1.5 billion in funding which must be divided to help over ninety countries. The program also splits the cost for the eradication of three different disease including malaria, tuberculosis, as well as AIDS/HIV. The cost of the production of the drugs for AIDS alone would exceed this amount, not only to mention the lack of support of medical supervisors and staff to administer these drugs.
Policy Option C
The last option that constitutes a combination of all possible options available makes it the best one. The project will be called the “AAA” or Action on Aids in Africa, and in alliance with the IMF, the World Bank, and the UN, the plan for eliminating the threat of AIDS in Africa will come to a close. Funding of $20 billion will be presented to the project over a five year initiative.
The goals of the plan are as follows:
· Every African living with HIV/AIDS should have access to lifesaving
antiretroviral therapy on or before December 2003.
· Every African pregnant woman should have access to life saving medicines that can reduce or elimate mother to child transmission of HIV on or before August 2003.
· Every African AIDS orphan should be in school and receive appropriate medical care on or before December 2003.
· The African nation should have enough resources to mount a credible information, education, and communication campaign against HIV transmission on or before August 2003.
· Every African country with five percent or more of its population living with
HIV/AIDS should have their debts cancelled and the savings channeled to
health and social programs on or before August 2003.
To conquer these goals, one-half of the funding will be provided toward treatment of patients with HIV/AIDS now. This treatment will include the most developed drug that may commonly be in practice among other parts of the world and will be offered from pharmaceutical companies at a lower rate per month for countries of national distress. A country shall be in national distress if over five percent of it’s population is infected with HIV/AIDS. The rate per month for the medicine will not exceed $350 a month.
Next, one third of the funding will be provided for the cost of prevention programs. These programs should also employ expert staff on the treatment of AIDS in poor countries while also providing funding for the start of intervention treatment centers. These will provide information on safe intercourse, along with provide information on condom use and abstinence.
The last of the funding will be geared toward the Cure With Water Act, this act shall state that all countries having been designated to receive such funds will be provided with clean water to rid off the chance of other diseases that may heighten the risk of having AIDS. Many of the drugs being used to treat such patients will require that the stomach be full of water, and the risk of water borne illnesses must be eradicated during this project.
With the help of the IMF, the AAA countries will receive assistance on help with rebuilding their states through aid administered in conjunction with the World Bank and other assistance programs such as UNAIDS and the Global Fund. Although a large increase in funding many points have been presented which if the case were presented about a problem of this stature ever happening in the U.S. that many would agree to it.
Policy Option C is clearly the best option for treatment and prevention of AIDS in Africa. The global coalition is key to help eliminate the threat of AIDS in Africa of becoming the modern day Black Death. Increasing funding helps build a strong and effective preventive care force to slow the disease’s death toll, while education will provide knowledge of new cultural behaviors.
To achieve the most moral solution, the problem can not be ignored any longer. What must be done is clear, and there are no other ways to go around the problem. AIDS is here to stay unless the people do something about it. People can not be left to die, no matter what race, when there are the resources out there to help educate and prevent such an epidemic from ever happening.
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