BANGKOK, THAILAND—Interventions for African American adolescent girls that are gender-tailored and culturally fitting can enhance HIV (human immunodeficiency virus)-preventive behaviors, skills, and may also reduce pregnancy and some sexually transmitted diseases (STDs), according to a study in the July 14 issue of JAMA, the Journal of the American Medical Association, a theme issue on HIV/AIDS.

Lead author Ralph J. DiClemente, Ph.D., from Emory University's Rollins School of Public Health and Center for AIDS Research, Atlanta, presented the findings from this study at a JAMA media briefing at the International AIDS Conference in Bangkok, Thailand.

According to background information in the article, adolescents are a known population at increased risk of HIV infection, especially African American girls. A recent study reported that "HIV prevalence among African American adolescent girls was significantly higher than among their white or Hispanic female peers and exceeds that of white, Hispanic, and African American male adolescents." African American girls in the South had the highest prevalence compared to girls from other regions of the U.S.

In this study, Dr. DiClemente and colleagues analyzed data from 522 sexually experienced African American girls aged 14 to 18 years who were screened from December 1996 through April 1999. The participants were randomized into two groups. The intervention group (n=251) received information on ethnic and gender pride, HIV knowledge, communication, condom use skills, and healthy relationships. The comparison group (n=271) received information on exercise and nutrition. All participants received four 4-hour group sessions. Data were collected at the start of the programs, and at 6- and 12-month follow-up.

"...participants in the HIV intervention were more likely to report using condoms consistently in the 30 days preceding the six-month assessment (75.3 percent vs. comparison, 58.2 percent) and the 12-month assessment (intervention, 73.3 percent vs. comparison, 56.5 percent) and over the entire 12-month period," the authors found. "Additionally, participants in the HIV intervention were more likely to report using a condom at last vaginal sexual intercourse, less likely to self-report a pregnancy, and less likely to report having a new vaginal sex partner in the 30 days prior to assessments." The authors add, "Promising intervention effects were also observed for self-reported pregnancy and laboratory-confirmed chlamydia. Because STDs, particularly chlamydia, are prevalent among adolescents and facilitate HIV transmission, even small reductions in incidence could result in considerable reductions in treatment costs as well as sizable reductions in HIV morbidity and its associated treatment costs."

BANGKOK, THAILAND—The use of the drug nevirapine is effective in reducing the risk of transmission of HIV at birth, but administration of a combination of nevirapine with the drug zidovudine to the baby does not improve outcomes, according to a study in the July 14 issue of JAMA, the Journal of the American Medical Association, a theme issue on HIV/AIDS.

Lead author Taha E. Taha, M.B.B.S., Ph.D., of the Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, presented the findings of the study at a JAMA media briefing at the International AIDS Conference in Bangkok, Thailand.

According to background information in the article, pre-birth counseling and human immunodeficiency virus (HIV) testing are not universal in Africa; thus, women often present in labor with unknown HIV status without receiving the standard HIVNET 012 nevirapine (NVP) regimen (a single oral dose of NVP to the mother at the start of labor and to the infant within 72 hours of birth). Information on the efficacy of adding zidovudine (ZDV) to a standard regimen of NVP is limited. This information is needed because most women in sub-Saharan Africa do not receive pre-birth antiretroviral treatment.

The researchers hypothesized that in situations in which the mother is tested for HIV at the time of presentation for delivery, giving two short drug regimens to the infant at birth would be more effective in increasing viral suppression and thus reducing mother-to-child transmission of HIV than a single regimen.

Dr. Taha and colleagues conducted a randomized trial between April 1, 2000, and March 15, 2003 at six clinics in Blantyre, Malawi, Africa. The trial included all infants born to 894 women who were HIV positive, received NVP intrapartum (during labor and delivery), and had not previously received antiretroviral treatment. Infants were randomly assigned to NVP single oral dose (n=448) and NVP (same dose) plus ZDV (n=446) for a week. Infants were enrolled at birth, observed at 6- to- 8 week visits, and followed up through 3 to 18 months. The investigators established the HIV status of 90 percent of all infants at 6 to 8 weeks.

The researchers found that the overall transmission at 6 to 8 weeks was 14.1 percent in infants who received NVP alone and 16.3 percent in those who received NVP plus ZDV. Excluding infections at birth in the study, the risk of transmission at 6 to 8 weeks was similar for infants who received NVP only (6.5 percent) and those who received NVP plus ZDV (6.9 percent).

Almost all infants were breastfed at week 1 and 6 to 8 weeks. Adverse events were comparable in infants receiving NVP only and NVP plus ZDV.

BANGKOK, THAILAND—The first 3-year double-blinded trial comparing antiretroviral therapies has found that the combination regimens being compared, one including tenofovir DF and the other stavudine, are equally effective, though tenofovir DF has more favorable outcomes with respect to cholesterol levels and the nervous system, according to a study in the July 14 issue of JAMA, the Journal of the American Medical Association, a theme issue on HIV/AIDS.

Lead author Joel E. Gallant, M.D., M.P.H., of the The Johns Hopkins University School of Medicine, Baltimore, presented the findings of the study at a JAMA media briefing at the International AIDS Conference in Bangkok, Thailand.

Highly active antiretroviral therapy (HAART) has transformed human immunodeficiency virus (HIV) infection into a chronic manageable disease, according to background information in the article. The article also indicates that although many regimens lower plasma viral load to below the limit of detection in most patients, maintaining a durable response remains challenging because of adverse effects, long-term toxicity, and complex dosing schedules, all of which can lead to nonadherence, virologic failure, and drug resistance.

To evaluate the safety and efficacy of tenofovir disoproxil fumarate (DF) treatment in patients who have not had antiretroviral therapy, Dr. Gallant and colleagues conducted a randomized, double-blind trial comparing tenofovir DF with stavudine, both given in combination with lamivudine and efavirenz. The study was conducted in 81 centers in the United States, South America, and Europe from June 9, 2000, to January 30, 2004. A total of 753 patients infected with HIV were screened and 602 patients entered the study. Patients were randomized to receive either tenofovir DF (n=299) or stavudine (n=303), with corresponding placebo, in combination with lamivudine and efavirenz. Efficacy was measured as the proportion of patients with an HIV viral load (plasma HIV RNA) of less than 400 copies/mL at week 48.

The researchers found that the proportion of patients with a viral load of less than 400 copies/mL at week 48 was 239 (80 percent) of 299 in patients receiving tenofovir DF and 253 (84 percent) of 301 in patients receiving stavudine. Equivalence was demonstrated in the secondary analyses (HIV RNA <50 copies/mL) at week 48 and through 144 weeks. Virologic failure was most often associated with efavirenz and lamivudine resistance.

Concerning safety, tenofovir DF was associated with a significantly lower average increase from baseline in fasting triglycerides, total cholesterol, directly measured low-density lipoprotein cholesterol, and a higher increase in high-density lipoprotein cholesterol. More patients required the addition of lipid-lowering agents in the stavudine group. Peripheral neuropathy (which includes pain or numbness in the feet or legs) and investigator-reported lipodystrophy (a condition characterized by changes in body fat distribution) were less common in the tenofovir DF group.

"This is to our knowledge the first large 3-year, randomized, double-blind trial of antiretroviral therapy in treatment-naive patients," the researchers write. "The high proportion of patients achieving HIV RNA level below limit of quantification through 144 weeks in both regimens is presumed to be due to a combination of the potency of the drugs used and the tolerability and simplicity of the regimens."

BANGKOK, THAILAND—Rapid testing for human immunodeficiency virus (HIV) provides timely results for women in labor which may permit a window of opportunity sufficient for interventions to decrease HIV transmission to the newborn, according to a report in the July 14 issue of JAMA, the Journal of the American Medical Association, a theme issue on HIV/AIDS.

Co-author Mardge H. Cohen, M.D., from Cook County Hospital, Chicago, presented the findings from the paper at a JAMA Media Briefing at the International AIDS Conference in Bangkok, Thailand.

"The Centers for Disease Control and Prevention (CDC) estimates that between 280 and 370 infants are born infected with human immunodeficiency virus (HIV) annually in the United States despite recommendations for universal prenatal HIV screening and widespread use of antiretroviral drugs in pregnant HIV-infected women," the authors provide as background information. "Perinatally [near birth] acquired HIV infections may result from missed opportunities for prevention, such as inadequate prenatal care. Ideally, all pregnant women should receive early prenatal care with voluntary HIV testing."

Lead author Marc Bulterys, M.D., Ph.D., from the National Center for HIV, STD, and TB Prevention at the CDC, and colleagues, analyzed the results from the Mother-Infant Rapid Intervention At Delivery (MIRIAD) study that implemented 24-hour counseling and voluntary rapid HIV testing for women in labor at 16 U.S. hospitals from November 16, 2001 through November 15, 2003.

There were 91,707 visits to the labor and delivery units in the study; 7,381 (8 percent of all visits recorded) of which were by eligible women without documentation of HIV testing. A total of 4,849 eligible women participated in the study. Blood samples were collected for both rapid testing and enzyme immunoassay (EIA), and if needed, Western blot testing.

"Factors independently associated with higher test acceptance included younger age, being black or Hispanic, gestational age less than 32 weeks, and having had no prenatal care," the authors report. In addition, "Median (mid-point) time from blood collection to patient notification of rapid test result was 66 minutes. In contrast, the median time from blood collection to receipt of EIA results was 28 hours, with more significant delays for specimens obtained on weekends vs. weekdays (39 vs. 25 hours)." ... "Thirty-four women tested HIV-1 positive with both rapid test and EIA, and all were confirmed by Western blot (prevalence = 7/1,000)," the authors found. For HIV-positive women identified, the median time between receipt of rapid test result and zidovudine prophylaxis provided to the mother in labor was 33 minutes. All HIV-exposed infants received antiretroviral prophylaxis soon after birth. To date, three infants in this study were found to be HIV-infected.

TAILORED HIV PREVENTION PROGRAM FOR AFRICAN AMERICAN TEEN GIRLS LEADS TO 30-40 % MORE CONDOM USE