News (Updated May 25,
2003)
[Home]
[Previous
news]
|
Tue May 20,11:48 PM ET
|
By Randy Dotinga
HealthScoutNews Reporter
TUESDAY, May 20 (HealthScoutNews) -- New research suggests that countless wives of drug users may be in danger of AIDS infection because their husbands are living secret lives.
In a survey, 71 percent of wives of at-risk addicts didn't know their spouses were having extramarital sex and using dirty needles.
"We actually blown away by the number of wives who reported that they had no idea what their husbands were up to," says study co-author William Fals-Stewart, a clinical psychologist at the University of Buffalo in New York. "It was surprising and disturbing."
It's not clear if the wives are truly in the dark or living in some sort of denial, Fals-Stewart says. But the research does suggest that many American women face potential AIDS infection without knowing they're at risk.
Fals-Stewart is an expert in couples counseling as a treatment for drug and alcohol use. He and his colleagues launched the study to help them understand what wives know about the high-risk behaviors of their husbands.
The researchers interviewed 362 men, mostly white, who were entering drug addiction recovery programs in upstate New York. They also separately interviewed the men's wives.
"We kept a firewall between the husband's report and the wife's report," Fals-Stewart says. "We told them we weren't going to share any information."
The findings of the study appear in the May issue of Drug and Alcohol Dependence.
Forty percent -- or 144 -- of the men admitted to engaging in activities within the past year that could have put them at risk of AIDS infection. They acknowledged having unprotected sex outside marriage (usually with a woman), using dirty needles during drug use or sharing needles, or all of the above.
Of the wives of the men at risk, 108 reported they didn't usually use condoms during intercourse with their husbands. Of that group, 77 (71 percent) said they didn't think their husbands engaged in risky activities. The rest said they did know they were at risk but didn't bother to protect themselves by insisting on condom use.
Fals-Stewart says it seems likely the men were telling the truth. It would be "bizarre" if they were to lie about drug use and extramarital sex, he says.
The findings raise the possibility that there is a large population of women at risk for AIDS who don't know it, Fals-Stewart says. To make matters worse, public health workers don't target these women for prevention, he adds. "It kind of raises the specter of extramarital sexual relationships as a public health issue," he adds.
Fals-Stewart says researchers are already testing whether it would be helpful to let couples in drug counseling know about the study findings. "We raise the specter to the wife that maybe her husband is engaging in high-risk behavior," he says.
However, the study findings make it clear that knowing about the risks they face doesn't always lead to protected sex.
The wives "may be in relationships where they feel that they can't negotiate that," says Charles J. Neighbors, an associate professor of psychiatry and human behavior at Brown Medical School in Providence, R.I.
Couples may also fear that condoms will reduce the emotional connection they feel during sex, he adds.
| Press Release | Source: The Immune Response Corporation |
Monday May 19, 5:30 am ET
Study by Bruce D. Walker, M.D., Massachusetts General Hospital, Division of AIDS, Harvard Medical School
"We welcome the intense peer review that preceded the publication of these results," commented John N. Bonfiglio, Ph.D., chief executive officer of The Immune Response Corporation. "Our newly established Scientific Advisory Board will use this data to help design future trials of REMUNE® in order to help accomplish our mission of establishing REMUNE®'s clinical benefit."
Specifically, the trial -- which was investigator-initiated and designed, double blinded and placebo-controlled -- demonstrated the induction of HIV-specific lymphocyte proliferation in all the chronically infected subjects who received REMUNE® and in none of those who received placebo. A total of 10 subjects participated, all of whom had viral loads controlled to less than 500 copies/ml for at least six months and CD4 cell counts of greater than 250 cells/mrn before starting ART.
While The Immune Response Corporation provided financial support and some reagents for the trial, the investigators generated, maintained and analyzed all related data using rigorous, prospectively defined criteria. The Immune Response Corporation did not participate in the preparation of the manuscript.
Trial data was originally presented at the XIV International AIDS Conference in Barcelona, Spain.
| Press Release | Source: CytRx Corporation |
Wednesday May 21, 8:30 am ET
- Secures Company's Worldwide Leadership Role in HIV Vaccine Development; Phase I Clinical Trial Scheduled to Begin Within Six Months -LOS ANGELES, May 21 /PRNewswire-FirstCall/ -- In a windfall step that prominently places the company at the center of DNA-based HIV vaccine development, CytRx Corporation today announced it has licensed from the University of Massachusetts Medical School (UMMS) the exclusive worldwide commercial rights to a novel DNA-based HIV vaccine. Additionally, $15 million has been awarded from the U.S. National Institutes of Health (NIH) earmarked specifically for the Phase I clinical study and evaluation of this vaccine technology.
"In the last decade there has been significant interest in and investment devoted to AIDS vaccine research and we believe the UMMS technology currently stands at the forefront of DNA-based HIV vaccine development," said Steven A. Kriegsman, the company's chief executive officer. "With this license, which includes a pending patent application with broad coverage claims, CytRx is in a strong and enviable position with regard to future products that leverage the potential of DNA-based HIV vaccines. We are very excited that our vaccine technology is incorporated in the NIH funded clinical study to begin within the next six months." Kriegsman noted that if the study is successful, it should open the door for further funding in more advanced clinical trials.
The lead vaccine candidates under development by Shan Lu, M.D., Ph.D., Associate Professor of Medicine at UMMS, seek to overcome certain obstacles that have challenged other HIV vaccine strategies. Among the challenges are the uses of antigens from laboratory strains of HIV or limited viral isolates that do not necessarily represent active strains existing in patients. Complicating this further are the many HIV subtypes that exist.
Dr. Lu's team has created HIV vaccines based on a unique cocktail of human HIV-1 primary isolates from several genetic subtypes of HIV. Advantages of this approach include what CytRx believes are a greater chance of maintaining efficacy despite the high mutation rate of HIV, a broader immune response against divergent HIV-1 glycoproteins and the possible ability to neutralize a wide spectrum of HIV-1 viruses.
Dr. Lu commented, "While there are significant hurdles to HIV vaccine development, mounting evidence exists for the use of DNA-based HIV vaccines in combination with various boosters to induce protective responses. The $15 million NIH grant permits Advanced BioScience Laboratories, Inc., which has a vaccine booster, to co-develop the vaccine with UMMS. Recent animal studies indicate promising immune response data and we look forward to advancing our vaccine candidates into the clinic."
According to the World Health Organization, in December 2002, more than 42 million people worldwide were living with HIV/AIDS. Approximately 5 million people were newly infected and HIV/AIDS caused 3.1 million deaths in 2002.
CytRx previously announced it formed a broad-based strategic alliance with UMMS, which included the signing of exclusive licensing agreements for the use of RNAi (RNA interference) technology in the development of therapeutic products within the fields of obesity, type II diabetes and cancer. The financial terms of the HIV license were not disclosed by the parties for competitive reasons.
|
Wed May 21, 5:23 PM ET
|
By Alicia Ault
NEW YORK (Reuters Health) - A surprising percentage of men who have sex with men do not know that the spermicide nonoxynol-9 offers no protection against HIV infection and might even enhance transmission, a recently released survey showed.
Researchers from the Centers for Disease Control and Prevention's (CDC) Division of HIV/AIDS Prevention interviewed 573 homosexual and bisexual men in the streets of the San Francisco Bay area in fall 2001.
The aim was to see if the men had absorbed warnings issued since 2000 by the CDC and the World Health Organization that nonoxynol-9 should not be used during anal intercourse.
Studies have shown that nonoxynol-9, a spermicide contained in some condoms and lubricants, offers no protection against sexually transmitted diseases and destroys the protective lining of the rectum, which may allow HIV to be more easily transmitted.
Overall, 61 percent, or 349, of the 573 men had heard of nonoxynol-9. Slightly more than half of the 349 had heard that it might not protect against HIV. Of men who knew about nonoxynol-9, 83 percent had used it -- 67 percent for anal intercourse in the previous year.
Of those who used it during anal sex, 41 percent did so without a condom because they thought it would protect against HIV transmission, according to a report in the journal AIDS.
"So even though they were hearing the message, it wasn't translating into behavioral change," said lead author Dr. Gordon Mansergh, a senior behavioral scientist at the CDC.
The researchers aimed for an even sampling of races, ages, and education and income. Twenty-nine percent were Latino, 28 percent African American, 28 percent Caucasian, and 15 percent other. The ages ranged from 18 to 67, and 38 percent were HIV-positive, 50 percent HIV-negative and 12 percent had an unknown status.
African Americans were more likely to say they would use nonoxynol-9 during anal intercourse. Latinos and those with unknown HIV status were less likely to have heard of nonoxynol-9 and therefore more likely to have unknowingly used it, according to Mansergh.
Though gay mens' understanding may have changed since the study period, the results show that public health officials need to be more targeted with their messages, especially when the message changes, Mansergh told Reuters Health.
Initially, nonoxynol-9 was thought to kill viruses, bacteria and other microbes, so public health officials encouraged its use for HIV prevention. But when studies published in 2000 showed it to be dangerous, officials reversed that recommendation.
In San Francisco, products with nonoxynol-9 were quickly removed from public clinics' shelves, and clients were counseled against using any such products.
SOURCE: AIDS 2003;17:905-909.
|
Wed May 21, 7:13 PM ET
|
Gus Cairns,
SUMMARY: The vast majority of HIV infections in the Netherlands among gay men are occurring between partners in long-term relationships, says a Dutch epidemiologist.
The vast majority of HIV infections in the Netherlands among gay men are occurring between partners in long-term relationships rather than via casual sex, a Dutch epidemiologist has found.
The safer-sex message seems to have endured better in the Netherlands than in the United Kingdom. Whereas 45 percent of British gay men reported having at least one experience of unprotected sex last year, in Holland the figure was only 25 percent.
However, the prevention messages were aimed squarely at encouraging condom use in casual sex. As a result, the vast majority of new HIV cases among gay men in Amsterdam are now occurring within steady, committed relationships.
Dr. Maria Xiridou of the Amsterdam Municipal Health Service found that no less than 86 percent of new HIV infections in the city were occurring within long-term relationships.
"Risk-taking with steady partners remains at high levels, and infection from steady partners is now the dominant mode of transmission," she told the Reuters Health press agency.
She added: "Different prevention measures may have to be developed in targeting high-risk behavior with each type of partner, such as counseling HIV-positive men and their steady partners." She also advocated that more attention be given to HIV testing for HIV-negative men who are in monogamous relationships with positive partners.
| Press Release | Source: Theratechnologies Inc. |
Thursday May 22, 8:01 am ET
"Undertaking this trial fits with our ThGRF program strategy aimed at making ThGRF a clinical and commercial success. Our pioneering work with this product has led to the identification of catabolic states as a very important set of indications to be developed, with our COPD and hip fracture wasting trials well advanced. Considering recent data showing clinical benefits with recombinant growth hormone in HIV lipodystrophic patients, and ThGRF's good safety profile, we simply could not miss the opportunity to increase the probability of success of ThGRF, by targeting another set of medical conditions where the lipolytic effect of ThGRF could be beneficial", said Dr. Thierry Abribat, Vice President and Chief Scientific Officer of Theratechnologies.
"Documenting the clinical efficacy of ThGRF in a new therapeutic field with a strong rationale will make ThGRF even more attractive for potential partners, as this will increase the chance of success for this potential blockbuster." added Mr. Luc Tanguay, President and Chief Executive Officer of Theratechnologies. "This new study is perfectly in line with our approach to develop safe products for diseases and conditions for which there is a definite medical need, for the benefit of both patients and society."
About the study
Theratechnologies will be conducting this Phase II, multicenter, double- blind, placebo-controlled study in 5 to 7 centres in Canada and the United States to assess the safety and obtain preliminary efficacy data of ThGRF (TH9507) in patients with HIV-related lipodystrophy. This trial, which has already been through the regulatory submission and clearance process, will include as lead investigators Dr. Steven Grinspoon, Director of the Program in Nutritional Metabolism at the Massachusetts General Hospital and Assistant Professor at the Harvard Medical School in Boston, and Dr. Julian Falutz, Director of the HIV Metabolic Clinic at the Montreal General Hospital and Assistant Professor at McGill University in Montreal. Up to 60 patients will receive a daily subcutaneous injection of two doses (1 mg, 2 mg, or placebo) over a period of 12 weeks in order to measure reduction of visceral and truncal adiposity. Various other parameters will be monitored, including cholesterol, insulin sensitivity, body composition and markers of bone metabolism. Finally, immune parameters will be measured in an exploratory manner, as ThGRF has been shown in an earlier study to stimulate the cell- mediated immune system, the component of the immune system that is specifically depressed in AIDS.
About HIV-related lipodystrophy
HIV-related lipodystrophy is a syndrome affecting a large number of HIV patients otherwise well controlled for HIV, and characterized by a number of abnormalities including accumulation of abdominal fat, increased cholesterol levels and glucose intolerance, which increase the risk of atherosclerosis and cardiovascular complications. HIV-related lipodystrophy raises other potential medical concerns, including non-compliance to HIV medication, and has a negative impact on quality of life. Among the estimated one million HIV patients in the United States, 40% to 50% of those under HAART (Highly Active Antiretroviral Therapy) experience or will experience signs of HIV lipodystrophy. Currently, there is no drug or therapy on the market capable of reversing this medical condition.
Large-scale studies have recently demonstrated that recombinant growth hormone, through its lipolytic action, effectively reduced trunk fat and visceral adipose tissue in patients with HIV-related lipodystrophy, while increasing lean body mass and decreasing non-HDL cholesterol levels (atherogenic or bad cholesterol). However, safety concerns are associated with the use of growth hormone based products in patients with glucose intolerance, a condition frequently found in HIV lipodystrophic patients. On the basis of existing Phase II results confirming ThGRF's safety in elderly and diabetic patients, Theratechnologies anticipates that ThGRF may not cause the side- effects associated with these products, due to its ability to induce growth hormone secretion in a physiological and pulsatile fashion. In addition, cholesterol reductions reported in the safety trial in diabetic patients support the rationale for the use of ThGRF in this category of patients.
About ThGRF
Theratechnologies' ThGRF is a multiactive product which induces the production of growth hormone in a natural, controlled and pulsatile fashion. ThGRF could offer benefits to patients in a number of therapeutic indications, without causing the side-effects commonly associated with growth hormone. Theratechnologies is currently pursuing a broad Phase II clinical program in a variety of indications including muscle wasting observed in chronic obstructive pulmonary disease and hip fractures, as well as certain metabolic, immune and cognitive dysfonctions.
| Press Release | Source: Antigen Express, Inc. |
Friday May 23, 8:00 am ET
The grant funds pre-clinical studies for a priority use of this HIV DNA vaccine to induce potent immune responses capable of preventing HIV infection and eradicating HIV in infected individuals.
Antigen Express scientists have pioneered strategies for enhancing helper T-cell responses to DNA vaccines by controlling the function of the immunoregulatory Ii-protein. The grant was awarded to test a novel, patented mechanism to increase the potency and repertoire of antigenic epitopes in a classical HIV DNA vaccine.
The Ii protein normally blocks the antigenic peptide binding site of MHC Class II molecules at time of synthesis in the endoplasmic reticulum of antigen-presenting cells. By suppressing the Ii protein by antisense methods, peptides which are transported into the endoplasmic reticulum to be bound by MHC Class I molecules also become bound to and presented by MHC class II molecules. Many novel epitopes also become presented, and at higher concentrations.
Antigen Express scientists and collaborators already demonstrated at least a six-fold enhancement in the immune response to an HIV gp120 DNA vaccine. This grant will expand these studies toward the completion of pre-clinical work to enable a clinical trial.
Boosting the antigen-specific T-helper cell response is critical to getting strong, prompt humoral and cytotoxic T-cell response for complete and rapid control of infection. Antibodies bind to and neutralize infectious viral particles while cytotoxic T-cells attack host cells, which synthesize the virus, before the virus is released into the circulation. In addition to increasing the immunogenecity, T-helper responses also induce immunological memory, which is very important for long-term protection.
This Ii protein immunoregulating platform technology has been also been applied by Antigen Express scientists to cure murine prostate, renal cell, and colon tumors (under other NIH SBIR grants).
Also, this platform technology is being adapted to rapid development of a novel SARS DNA vaccine in collaboration Generex Biotechnology. Antigen Express was founded in 1995 around the laboratory group of Robert Humphreys, M.D., Ph.D., then Professor of Medicine and Pharmacology, and interim Chair of Pharmacology at the University of Massachusetts Medical School. Dr. Humphreys trained at Yale, the National Naval Hospital in Bethesda, and Harvard. The company operated in incubator of the Massachusetts Biotech Ideas until 1997 and has had 9 NIH grants.
Antigen Express holds 6 US and several foreign Patents covering its proprietary technologies. Dr. Humphreys has more than 60 papers on mechanisms and drug leads for current Antigen Express products in development.