For many people in our community, living with HIV is not easy. Nobody wants to think about having an incurable disease, getting sick, or dying. This is especially difficult with HIV because the disease is largely transmitted in younger and sexually active people.
The AIDS Treatment Activists Coalition (ATAC) was formed roughly 1 year ago at a meeting in Houston of national HIV/AIDS activists. The group spent several days discussing the treatment challenges of people with HIV/AIDS and the need for effective advocacy in areas such as novel therapies, vaccines, and microbicides (used during sexual intercourse to prevent transmission of HIV).
The International AIDS Conference occurs every 2 years and most recently was held in Barcelona, Spain, in July 2002. The meeting draws many thousands of researchers, doctors, social and health care workers, people with HIV/AIDS, political figures, and religious leaders.
Much of the information that you read in HIV Treatment ALERTS! is geared towards how to use drugs to manage HIV infection. The next few paragraphs will discuss something even more important: how to keep receiving those very drugs.
Some people with HIV experience what is commonly known as lipodystrophy, which includes such symptoms as fat loss in the face, arms, and legs and/or fat gain in the gut, breasts, or back of the neck. A study called "ACTG A5110" is looking at whether fat loss in the arms and legs is caused by specific types of anti-HIV drugs.
When individuals are faced with HIV/AIDS, their physical health is not the only issue at hand. Along with the physical illness associated with the virus are mental health conditions. Common psychological disorders associated with HIV/AIDS are depression, anxiety, and sometimes dementia (AIDS Dementia Complex or ADC).
We have all heard the lipid (blood fat) story with many of the currently available protease inhibitors—cholesterol can go through the roof and the triglycerides are just not pretty. The worry, of course, is what a cholesterol count of 300 or 400 might do in the long term.
Media coverage of the growing number of cases of West Nile Virus infection has been almost constant over the past few months. There is no doubt that the virus is spreading throughout North America and eventually may become an epidemic, but what does this mean for people with HIV/AIDS?
Steven's House is a small, intermediate-care facility for people living with AIDS. By establishing a home-like living environment, this organization offers care to residents and people in their support network 24 hours a day, 7 days a week. Steven's House is open to both men and women. The goal of Steven's House is to help people with AIDS to return to independent living.
Sometimes taking a step back and looking at the "whole picture" helps us gain a better understanding of a situation. This issue of RITA! does exactly that by providing an overview of HIV therapeutic development. In a time when we are considering second and even third generation anti-HIV drugs, it may very well be useful to pause for a second and take a fresh look at the landscape of HIV therapeutic development. However, the processes of developing anti-HIV drugs and conducting clinical trials are only part of this landscape. There is also a history of activism that has resulted in change: accelerated approval, treatment advocacy, and community representation at government and industry tables.
Once a drug candidate has been identified and undergone study in the laboratory and animals, it enters clinical trial, usually composed of 3 phases. Generally, as the drug candidate goes from phases 1 to 3, the number of volunteers exposed to it increases and the duration of study lengthens. Each phase serves a unique purpose, and each builds on the knowledge gleaned from the earlier research.
The Food and Drug Administration (FDA) is one of several government agencies charged with protecting, promoting, and enhancing the health of the American people. The statutory authority of the agency is the Food and Drug Administrative Modernization Act enacted in November 1997 that amended the Federal Food, Drug, and Cosmetic Act. In the broader sense, the FDA is charged with ensuring that food and cosmetic products, as well as radiation-emitting products, are safe. In addition, it regulates feed and drugs for pets and farm animals.
www.FDA.gov: FDA home page with consumer education material, press releases, industry guidance, bulletins for health professionals, and other information and data....
Accelerated drug approval was one of most important accomplishments of early AIDS activism. In a sense, it was the "final draft" of several earlier proposals, all of which pursued the same goal: getting new drugs to people in need more quickly. Accelerated approval differed from earlier, similar proposals in that it resulted in putting the drug in pharmacies for sale. The earlier approaches also made experimental drugs available, but only through special programs and often through a limited number of physician's offices. Collectively, these programs helped bridge the gap between concerns over the safety of unproven drugs and the needs of people who often had nothing to lose. Fortunately, in more than a decade of speedier access to new drugs, no drug that posed an unacceptable safety risk was unleashed on the HIV-infected public. Sheer luck, some say, since the risk of diminished safety was always understood to be part of the bargain.
For several years now antiretroviral therapies have been the means by which many HIV-infected persons have managed to stave off disease and death. Yet despite the apparent success of antiretrovirals, their use as the sole therapeutic approach to HIV disease has many limitations. The most glaring of these limitations is, of course, access. Antiretrovirals are only useful for patients who can access them either through insurance, government subsidy, or some other means. This leaves out a vast majority of the world's HIV-infected population.
The development and approval of immune-based therapy (IBT) for the treatment of HIV infection and related conditions is complicated by many factors, not the least of which is a poor understanding of immune responses that promote health and prolong life in people living with HIV. Defining the goal of and how best to use an IBT is an arduous task in itself. Figuring out a way to design studies quickly and efficiently to assess the value of IBTs is even more daunting. Interleukin-2 (IL-2, also known as Proleukin) is an IBT furthest along in study in the context of HIV disease. Using IL-2 as an example, this article will explore the obstacles and challenges to developing IBTs for the treatment of HIV infection.
Recently, yet another friend and colleague died of AIDS. Linda Grinberg, head of the Foundation for AIDS and Immune Research, died in her sleep of a heart attack brought on by primary pulmonary hypertension (PPH), which she developed a year ago. PPH is a rare cardiac phenomenon, but can be brought on by HIV infection. Linda was a fearless AIDS treatment activist who had faced death many times since her T cells plummeted to 30 back in 1995. As a straight woman, a child-of-Hollywood with its wealth and privilege who lived in a swanky suburb of Los Angeles, she didn't need to devote her time or her money to pushing for new treatments for HIV, but she did—with a determination that belied her failing health. She was the driving force behind the Coalition for Salvage Therapy, pushing for faster access to new antiretroviral agents, and the Structured Treatment Interruptions Workshops, which brought together leading researchers to figure out if these stops and starts in therapycould have some benefit, or at least do no harm.
This is the second year of HIV Treatment ALERTS! and we hope you find this newsletter helpful and informative. The science and medicine of HIV change constantly. The "best" way to treat HIV today could be very different tomorrow. That's what HIV Treatment ALERTS! is for—to keep you informed of the latest changes in HIV medicine: new drugs, drug warnings and interactions, ways to treat side effects, clinical trial information, useful websites and phone numbers, special reports, and much more.
Do doctor visits make you nervous? When you are sitting in the exam room with your health care provider, do you suddenly forget what you wanted to talk about? Try these 3 simple tips to prepare yourself and make the most out of each visit.
The Annual Retrovirus Conference is the major HIV research meeting in the US. Each year, several thousand healthcare providers, researchers, and community activists meet for 5 days to review the latest developments in the field of HIV. Information at the conference covers new anti-HIV drugs, drug interactions, side effects, vaccine research, and more.
No, this isn't an article about problems with your voice box. It's a reflection of what has been happening around The Center for AIDS (The CFA) lately. Our client traffic and phone calls often keep us informed of what is "seen and heard" on the street, and lately we have noticed that things are kind of quiet out there.
The Montrose Clinic is now enrolling patient volunteers for a study of multi-drug resistance. The study (called CPCRA 064) will use viral resistance testing to see what drugs might still work against a patient's HIV. From the resistance tests, new drug combinations will be figured out that hopefully should work against the virus. Two groups of patients will be studied: one that starts the new drug regimens right away, and one that starts the new drug regimens after a 4-month treatment interruption.
Viread is supplied in 300-mg tablets that are almond shaped, light blue film coated, and embossed with "GILEAD" and "4331" on one side and with "300" on the other side.
The Food and Drug Administration (FDA) has approved an official recommended dose for combining the protease inhibitors amprenavir (Agenerase) and ritonavir (Norvir). When the two are used in combination, 1200 mg of Agenerase can be given with 200 mg of Norvir once a day, or 600 mg of Agenerase can be given with 100 mg of Norvir twice a day. The small amount of Norvir is used as a "boost" to increase the levels of Agenerase in the blood. In the case of Agenerase, which is one of the largest anti-HIV pills, this combination also helps reduce the number of pills needed.
Getting high may damage the immune system: A study of specially bred mice transplanted with human immune cells has shown that cocaine increases the production and spread of HIV. Mice given cocaine by injection had much greater losses of T cells and increases in viral load than mice given ordinary salt water (used as a control).
Bread of Life began in 1992 as an outreach program of St. John's United Methodist Church. A cornerstone of this downtown Houston organization is its Daybreak Community Health Center, which offers health care services to uninsured or indigent individuals. Many Bread of Life services address the needs of children and adults with HIV/AIDS, as well as at-risk groups and the homeless.
At a recent working retreat for the staff of The Center for AIDS, I reflected on the year 2001 and judged it to be a "bad" year. In my mind (and others' I am sure) there are good years and bad years, and 2001 was a bad year.
Researchers have expended much time and effort studying primary HIV infection (PHI). Large amounts of money have been spent identifying patients in the earliest stage of HIV infection, studying their immune responses, and conducting studies of therapeutic interventions. Given that the entire course of HIV disease spans years as opposed to the weeks or months of PHI, it is logical to ask, what is the urgency of identifying persons experiencing PHI? Why intervene with aggressive antiviral therapy given that most symptoms associated with PHI are self-limited and that current trends in treatment are leaning towards waiting longer before initiating therapy? Why study immune responses during this brief period of acute illness?
The US Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents recommend treating patients during primary HIV infection. The rationale for this recommendation is largely theoretical and is based on results from clinical studies involving a relatively small number of patients, cellular immune responses, and other laboratory markers. Indeed, many of the scientific findings that justify treating patients during PHI are recent and have yet to be validated in larger cohorts of patients. There are no answers to critical questions such as "How long should treatment last?" or "What combination of therapy should be used first?" Nonetheless, some of the data gathered to date on the effects of treatment during PHI are intriguing and indicate that such treatment may alter the nature of the patient's disease course, from shifting viral "set point" and decreasing the degree of viral"seeding" to potentially preserving some HIV-specific immune function.
The following cases illustrate the complexities involved in recognizing and correctly diagnosing primary HIV infection (PHI). Extensive lab work, but also thorough history taking, is required. Patient 1 was not recognized as suffering from PHI until after she was discharged from the hospital. Patient 2 was recognized with PHI, and his symptoms spontaneously resolved. Patient 3 required extensive hospitalization because of pulmonary complications. Viral loads declined sharply without medication for both patients 1 and 2, upon resolution of symptoms. However, patient 3 maintained a high viral load and was started on triple-drug antiretroviral therapy. None of the patients were started on antiretroviral therapy during the acute retroviral syndrome phase of PHI, which is currently recommended in US treatment guidelines.
Except for advanced practitioners, registered nurses do not diagnose. But a proper nursing assessment, which includes physical examination, history taking, and review of laboratory studies, can go a long way in aiding an accurate medical diagnosis. In many health care settings, patients encounter a registered nurse well before seeing a physician or nurse practitioner. Assessment and history taking begin with the nurse.
One goal of diagnosing patients with primary HIV infection (PHI) is to treat them with highly active antiretroviral therapy (HAART) potentially to alter their disease course. The hypothesis is that such treatment will preserve immune function, limit the development of viral diversity, and perhaps alter the viral "set point." The extent to which this intervention accomplishes these goals is still to be determined by clinical and scientific study. A second proposed and perhaps less well-known goal of treating PHI is to alter the epidemic spread of HIV infection by treating patients during a time when, because of biological factors and behavioral patterns, they may be highly infectious and likely to spread the virus to others.
The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) sponsors pathogenesis and clinical research of primary (acute) HIV infection through the Acute Infection and Early Disease Research Program (AIEDRP). AIEDRP performs innovative, integrated, investigator-initiated pathogenesis and clinical research on acute and early HIV-1 infection. The program was established in 1997 and now consists of 9 participating research units. In addition to conducting research in the United States, some of the AIEDRP units have international research sites, such as Zambia and Brazil.
Primary HIV infection is the period of a few weeks or months after a person becomes infected with HIV. During this time a person may have symptoms that resemble the flu or mono (mononucleosis). During primary HIV infection a person will not test positive using standard HIV antibody tests (ELISA) even though he or she is infected.
This information is designed to support, not replace, the relationship that exists between you and your doctor.