Trial to Review Sex Differences in HIV Treatment

At the 1999 National Conference on Women and HIV/AIDS, details were announced about the largest clinical trial ever held to determine sex differences in HIV treatment. The trial is called A.T. L.A.S.T. (Antiretroviral Trial Looking at Sex and Treatment), and it will compare clinical outcomes of a group of women and men for whom current treatments have failed. The study will also help doctors determine whether men and women should be prescribed the same dosages of drugs, and may help explain the gender gap in survival rates between men and women with AIDS. The trial was designed by a unique group of collaborators: Women Alive, clinical investigators, Bristol-Myers Squibb, and Merck & Co. Study participants will receive two NRTIsxstavudine, also known as Zerit, and didanosine, known as Videxxalong with the protease inhibitors indinavir (Crixivan) and ritonavir (Norvir). It will assess this regimen's value to patients already experienced with NRTI and NNRTI treatments. Investigators will compare viral load suppression, diabetes, lipodystrophy, and elevated cholesterol levels in 100 women and 100 men, who will be enrolled at ten sites in the US. The study is unique in a number of ways. It takes into account the problems of daily living experienced by people living with HIV/AIDS, and attempts to promote adherence through a number of support systems. Peer educators and patient advocates will play important roles in providing education, emotional support, and, sometimes, financial support for child care and transportation. Peer advocates will wear pagers, so that they will always be available to provide support. DeAnna Bowens, Women Alive's peer advocate coordinator, explained that the goal was to prevent any participant from having to drop out because of the "demands of day-to-day life.

HIV/AIDS Rates Among African Americans & Women

The CDC has reported that HIV/AIDS continues to disproportionately affect the African American community. The disease has also spread significantly among women, and women of color have seen the largest increases. Although African Americans make up 12% of the US population, 37% of all AIDS cases reported to the CDC from the beginning of the pandemic through December of last year were among people of color. The number of African Americans reported with AIDS surpassed that of any other racial or ethnic group in 1998 at 45 percent (21,752 cases out of 48,269 reported were among African Americans). In the same year, the rate of reported AIDS cases among African Americans was two times higher than among Hispanics, and eight times greater than among whites. CDC numbers show that almost two-thirds of women (62 percent) and children (also 62 percent) reported with AIDS were African American. The category "women of color," comprising African American and Hispanic women, makes up 77 percent of AIDS cases reported since the beginning of the pandemic. In the United States, African American women aged 25-44 are more likely to die of AIDS than of any other cause.

Prevention and African Americans

With such disturbing trends, prevention efforts must be strengthened, and successful strategies must be sustained. Among women and minority populations, safe sex must be stressed. In the African American community, men who have sex with men made up 38% of AIDS cases since the pandemic began, and in 1988, most women were infected through heterosexual contact. Prevention efforts among both groups should also focus on drug use. Injection drug use accounted for 35% of all AIDS cases since the beginning of the pandemic among adult and adolescent African American men, and 44% of adult and adolescent African American women. Drug use often played a part even among women infected through heterosexual contact, since these women may have been infected through sex with a drug user, or may have exchanged sex for drugs or money. The conjunction of drug use and sexual HIV infection is extremely important, especially for women, and should be addressed with appropriate prevention strategies. The CDC called on African American community leaders to acknowledge the presence of HIV/AIDS and to augment public health efforts in fighting the spread of the disease. Successful behavioral and biomedical prevention strategies must also be easy to access. Young women and women of color would also benefit from increased and easily accessible prevention and treatment services. Female-controlled methods of prevention are scarce, and female condoms and topical microbicides are among the newer methods being currently evaluated.

Three Studies Support Viramune Use

Three studies have indicated possible new roles for Viramune (also called nevirapine or NVP) in the treatment of HIV/AIDS. First, Viramune was shown to be as effective as a protease inhibitor when used in combination with two nucleoside analogues, thus giving physicians protease-sparing strategy. In the study, Viramune plus stavudine and didanosine were as effective at reducing viral loads to undetectable levels as a protease inhibitor plus stavudine and didanosine. These results were consistent even among patients with relatively high baseline HIV levels (>51,286 copies/ml). Viramune was used once daily in the study, providing patients with an easier alternative to other dosing regimens. In the second study, conducted in Uganda by the National Institute of Allergy and Infectious Diseases' HIV Prevention Trials Network, Viramune was shown to be twice as effective as ZDV in reducing mother-to-infant HIV transmission. Even more surprising was the dosage involved. Women in labor were given one oral dose (200 mg tablet) of Viramune, and another single dose (2 mg/kg oral suspension) was given to the newborn within three days of birth. The ZDV regimen was much more complicated and expensive-600 mg at the onset of labor, then 300 mg every three hours for the duration of labor. Four mg/kg of ZDV were given twice a day to the newborn for seven days after delivery. None of the women in the study had previously taken any antiretroviral drugs. This data has not yet been reviewed by US regulatory agencies. Finally, in an international clinical endpoint study called BI 1090, a combination of Viramune, zidovudine (ZDV) and lamivudine (3TC) suppressed HIV for up to one year in patients with advanced HIV disease and high baseline viral loads. It was also effective in suppressing HIV in patients with lower viral loads. According to Dr. Richard Pollard of the University of Texas Medical Branch at Galveston, Texas, the patients' mean baseline CD4+ count was 86 cells/mm3, and mean baseline viral load was 145,821 copies/mL. HIV levels of these patients dropped to below 400 copies/mL at some time during the study for 86% of patients in the study, and 68% were still below that level at one year. In addition, after one year, 42% of patients with a low baseline viral load (<100,000 copies/mL) and 55% of patients with a high baseline viral load (>100,000 copies/mL) had an undetectable viral load (<50 copies/mL). The study compared patients taking a combination of nevirapine, ZDV and 3TC with patients taking only ZDV and 3TC. At the end of 12 months, 49% of all study participants taking the combination including nevirapine had less than 50 copies/mL, compared with 0% of patients on ZDV and 3TC alone. And, CD4+ cells were up by 109 from baseline for patients on nevirapine, compared with an increase of 56 for patients on ZDV and 3TC.

ABT-378/r Shows Promise in Two Studies, And Is Offered in Early Access Program

At the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), investigators presented two studies that suggested that at 36 weeks, Abbott Laboratories' new investigational agent, currently called ABT-378/ritonavir (ABT-378/r), demonstrated antiretroviral activity, and was tolerated by both treatment-naïve and experienced patients. In the first study, over 95 percent of antiretroviral-naive patients had HIV RNA lower than 400 copies/mL after 36 weeks of treatment, and 89 percent of those patients' viral load was below the level of detection (50 copies/mL). In a separate study, after 36 weeks of treatment, 78 percent of patients had HIV RNA of less than 400 copies/mL. In this study, patients had previously been treated with one protease inhibitor and two NRTIs. All patients had demonstrated significant viral resistance to drugs they had previously used. As a result of these studies, ABT-378/ritonavir will be made available to a limited number of people meeting certain treatment criteria. This early access program will allow some patients access to the drug before it is submitted to the FDA for approval. Because supply is limited, only a small number of people will be able to enroll immediately. The company plans to extend enrollment as soon as more of the drug is produced. Eligible patients must have documented failure and/or intolerance to at least two protease inhibitors, an HIV RNA plasma titer greater than 10,000 copies/mL, and a CD4 cell count less than 50 cells/mm3 within the past three months or an active AIDS-defining opportunistic infection while on HAART. The criteria may change according to drug availability. For additional information, call 1-. Abbott expects to file a New Drug Application for ABT-378/r in the year 2000.

UNAIDS Reports That AIDS Epidemic Not Slowing

According to a report released November 23rd by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO), since the beginning of the epidemic, 50 million individuals worldwide have been infected with HIV, of whom more than 16 million have died and 33 million are living with the virus. The report also states that a record 2.6 million people died of AIDS this year, with 5.6 million becoming infected. UNAIDS has identified three trends in the report that exemplify the state of the epidemic in 1999. In sub-Saharan Africa, new evidence shows that 55 percent of infected adults are women, with life expectancy in southern Africa likely to drop to as low as 45 by 2010. The steepest increase in HIV infection occurred in the newly independent states of the former Soviet Union--seeing the HIV-infected population double between 1997 and 1999, mostly due to injection drug use. And finally, prevention efforts in countries such as Thailand, India and the Philippines have had success in reducing HIV risk and lowering or stabilizing HIV infection rates, and some Latin American countries have begun providing antiviral drugs to people infected with HIV. "There is no room for complacency in any discussion of this epidemic. The threat of HIV has not diminished in any country. We have even seen evidence from North America and Western Europe suggesting that availability of life-prolonging therapies may be contributing to an erosion of safer sexual behaviour. This is tragic," said Dr. Peter Piot, UNAIDS Executive Director. The report AIDS Epidemic Update-December 1999, can be found online at http://www.unaids.org/whatsnew/ press/eng/index.html.

AIDS Nutrition Services Alliance Conference Largest Ever

Over three hundred participants, the largest to date, took part in "Food Fight 1999: Combating HIV through Nutrition" held in Atlanta Georgia. ANSA's conference provides a vital forum for the nation's leading dieticians practicing in HIV and over 80 member agencies from across the U.S., who provide 10 million meals annually to 25,000 men, women, and children living with HIV/AIDS. This year ANSA offered 50 workshops covering a variety of issues relevant to HIV nutrition providers including resource development, client and volunteer services, administration, nutrition, kitchen and food services, and distribution and delivery. To become a member of ANSA or to learn more about membership benefits, please contact Alison Drone, Assistant Director by phone at or by e-mail at .

THC Based Appetite Stimulant Down-Scheduled By The DEA

The Drug Enforcement Administration (DEA) in an unprecedented action has rescheduled dronabinol (Marinol), an appetite stimulant, from a tightly controlled Schedule II to a Schedule III drug. This will ease the prescribing restrictions imposed on physicians choosing to prescribe the medication. Schedule II drugs often require triplicate prescriptions and cannot be ordered over the phone or refilled. Marinol, a synthetic THC, the active ingredient found in Marijuana, has been proven safe and effective medication for the treatment of appetite loss associated with AIDS and anorexia. The decision to reschedule Marinol was greatly influenced by the support of the Food and Drug Administration (FDA), The National Institute on Drug Abuse (NIDA), and the findings of a study completed by the Haight Ashbury Free Clinics, which concluded that Marinol has a low abuse potential and diversion is virtually non-existent. The most common side effects involve the central nervous system and include sleepiness, dizziness and euphoria (or giddiness). The new reclassification will now allow doctors and patients easier access to the benefits of the medication.

Testosterone Gel Effectively Restores Male Hormone

Preliminary Results of a phase III comparative clinical trial indicate that Androgel, a dermally applied testosterone replacement gel, is well tolerated and effectively restores serum levels of the male hormone. A large U.S. multicenter evaluated 227 men aged 18 to 68 affected by hypogonadism, the inadequate production of the male hormone testosterone. Men were randomly assigned to either apply one or two Androgel doses daily or to wear a currently marketed testosterone patch. Men were then monitored for up to 180 days, with primary monitoring points at 30 and 90 days. In addition to measuring serum testosterone levels, the study also measured the effects of testosterone replacement therapy on libido, body cell mass, muscle strength and body fat. The results with Androgel are consistent with finding from other studies that show positive effects of testosterone replacement on sexual behavior, body mass composition and mood. Androgel is being developed by Unimed Pharmaceuticals, Buffalo Grove, Illinois.