April 19, 2012
2 min read

HPTN 035: Genital tract inflammation increased risk for HIV among women

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Bacterial activity in the genital tract increased the susceptibility of HIV infection among women, but hormonal contraception did not, data from two studies suggest.

Researchers from the NIH-funded Microbicide Trials Network reported the findings during the International Microbicides Conference in Sydney, Australia, both of which came from the HPTN 035 trial — a phase 2/2b clinical trial assessing the safety and effectiveness of two vaginal microbicides.

Bacterial activity

For the first study, researchers from the University of Pittsburgh evaluated whether soluble mucosal immunity affected the risk for HIV, independent of the use of the microbicide. During the trial, 3,524 endocervical swabs were collected from 2,031 women. Pre- and post-seroconversion swabs from 26 women who seroconverted on trial were analyzed and compared with 116 controls.

No significant differences were observed in the swabs before and after HIV acquisition among the women who seroconverted. Compared with controls, however, women who acquired HIV had significantly more anti-Escherichia coli activity and were more likely to have detectable human beta-defensin-2 in their pre-seroconversion sample. In multivariate analysis, only total protein and anti-E. coli activity remained statistically significant.

“We don’t understand exactly what this assay is telling us other than these women had some underlying level of immune activity that placed them at greater risk,” Charlene Dezzutti, PhD, of the University of Pittsburgh, said in a press release. “We’d like to be able to identify women who may be more susceptible to HIV — before they become infected — but there is still more work ahead. We need to test the approach in more samples and dig deeper.”

Hormonal contraception

In the second study, researchers found that neither injectable nor oral contraceptives increased the risk for acquiring HIV.

Researchers from the University of Zimbabwe conducted a retrospective review of data from the HPTN 035 trial that included 2,887 women from Africa. Among these women, 51% reported using an injectable contraceptive, 21% reported using oral contraceptives and 14% used nonhormonal contraception.

Women who used injectable hormonal contraception had no statistically significant association of risk to HIV acquisition, with a Hazard ratio of 1.4. Oral contraceptive users also had no significant risk for HIV acquisition, with a Hazard ratio of 0.86.

“In many ways, our data reflects the overall body of evidence so far, which has seen inconsistent study results,” Zvavahera Mike Chirenje, MD, of the University of Zimbabwe, said in a press release. “If there’s one conclusion to be made from our analysis, as well as the other studies to date, it’s that there are no clear answers about hormonal contraception and HIV risk.”


  • Chirenje ZM. Association between hormonal contraception and HIV infection in HPTN 035.
  • Dezzutti CS. Increased genital tract inflammation is associated with HIV-1 seroconversion in women participating in the HPTN 035 trial.
  • Both presented at: International Microbicides Conference; April 15-18, 2012; Sydney, Australia.


  • The researchers report no relevant financial disclosures.