Tenofovir for Preventing HIV in Women
Author Information
Author(s): Peterson Leigh, Taylor Doug, Roddy Ronald, Belai Ghiorghis, Phillips Pamela, Nanda Kavita, Grant Robert, Clarke Edith Essie Kekawo, Doh Anderson Sama, Ridzon Renee, Jaffe Howard S, Cates Willard
Primary Institution: Family Health International
Hypothesis
Does a daily dose of tenofovir disoproxil fumarate (TDF) prevent HIV infection in women at high risk?
Conclusion
Daily oral use of TDF in HIV-uninfected women was not associated with increased clinical or laboratory adverse events, but effectiveness could not be conclusively evaluated due to the small number of HIV infections observed.
Supporting Evidence
- The study enrolled 936 HIV-negative women at high risk of HIV infection.
- Participants were randomized to receive either TDF or placebo.
- Eight seroconversions occurred during the study, with two in the TDF group and six in the placebo group.
- The study found no significant differences in safety outcomes between the treatment groups.
- Only two sites contributed data for the primary safety analyses.
Takeaway
The study tested a pill to see if it could stop women from getting HIV, but not enough people got infected to know if it worked.
Methodology
This was a phase 2, randomized, double-blind, placebo-controlled trial conducted in Ghana, Cameroon, and Nigeria.
Potential Biases
Potential bias due to the closure of study sites and the inability to achieve the planned follow-up.
Limitations
The study was limited by the premature closure of two sites, which reduced the power to assess differences between trial arms.
Participant Demographics
HIV-negative women aged 18 to 35 at high risk of HIV infection.
Statistical Information
P-Value
0.24
Confidence Interval
0.03–1.93
Statistical Significance
p = 0.24
Digital Object Identifier (DOI)
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