Tenofovir disoproxil fumarate for prevention of HIV infection in women: a phase 2, double-blind, randomized, placebo-controlled trial.

ObjectivesThe objective of this trial was to investigate the safety and preliminary effectiveness of a daily dose of 300 mg of tenofovir disoproxil fumarate (TDF) versus placebo in preventing HIV infection in women.DesignThis was a phase 2, randomized, double-blind, placebo-controlled trial.SettingThe study was conducted between June 2004 and March 2006 in Tema, Ghana; Douala, Cameroon; and Ibadan, Nigeria.ParticipantsWe enrolled 936 HIV-negative women at high risk of HIV infection into this study.InterventionParticipants were randomized 1:1 to once daily use of 300 mg of TDF or placebo.Outcome measuresThe primary safety endpoints were grade 2 or higher serum creatinine elevations (>2.0 mg/dl) for renal function, grade 3 or 4 aspartate aminotransferase or alanine aminotransferase elevations (>170 U/l) for hepatic function, and grade 3 or 4 phosphorus abnormalities (<1.5 mg/dl). The effectiveness endpoint was infection with HIV-1 or HIV-2.ResultsStudy participants contributed 428 person-years of laboratory testing to the primary safety analysis. No significant differences emerged between treatment groups in clinical or laboratory safety outcomes. Study participants contributed 476 person-years of HIV testing to the primary effectiveness analysis, during which time eight seroconversions occurred. Two were diagnosed in participants randomized to TDF (0.86 per 100 person-years) and six in participants receiving placebo (2.48 per 100 person-years), yielding a rate ratio of 0.35 (95% confidence interval = 0.03-1.93), which did not achieve statistical significance. Owing to premature closures of the Cameroon and Nigeria study sites, the planned person-years of follow-up and study power could not be achieved.ConclusionDaily oral use of TDF in HIV-uninfected women was not associated with increased clinical or laboratory adverse events. Effectiveness could not be conclusively evaluated because of the small number of HIV infections observed during the study

SEXUAL TRANSMISSION OF HIV

Transmission through sexual contact accounts for 75 to 85 percent of the nearly 28 million infections with the human immunodeficiency virus (HIV) that have occurred so far.1 The probability of infection through sexual contact, although it varies greatly, appears to be lower than that of infection through other routes of exposure (Figure 1). The variability observed among and within routes of HIV exposure depends partly on the viral dose and also on whether the virus is transmitted directly into the blood or onto a mucous membrane. In addition, these differences are influenced by a variety of host factors, including both factors common to all routes of exposure and those unique to sexual transmission. HIV infectivity is the average probability of transmission to another person after that person is exposed to an infected host. Infectivity plus two other parameters — the duration of infectiousness and the average rate at which susceptible people change sexual partners — determines whether the epidemic grows or slows.12 On a population level, all three corners of the classic epidemiologic triangle — host-related factors (susceptibility and infectiousness), environmental factors (the social, cultural, and political milieu), and agent factors (HIV type 1) determine HIV infectivity. Host-related and environmental factors can amplify the epidemic through their dual effect on infectivity and the rate of sexual-partner change. Although the entire triangle is key to understanding infectivity, our article focuses on the epidemiology and biology of the host-related factors that affect the sexual transmission of HIV

Family Planning and the Millennium Development Goals

The United Nations' (UN's) eight Millennium Development Goals (MDGs) (1) are widely accepted as the primary path to alleviating poverty worldwide. This month, world leaders convene to assess progress toward these goals (2). In the countdown to the MDG 2015 deadline and amid protracted economic recession, we need the most efficient, effective, and evidence-based means to accelerate progress toward all MDGs. Challenges must be considered in concert, and solutions must provide multidimensional dividends for the world's poor, or we risk unwisely dividing limited resources and diluting their impact. As authors from diverse communities, we emphasize here the influence that investments in rights-based family planning can have on achieving the MDGs

Reproductive choices for women with HIV

Access to reproductive health services for women with HIV is critical to ensuring their reproductive needs are addressed and their reproductive rights are protected. In addition, preventing unintended pregnancies in women with HIV is an essential component of a comprehensive prevention of mother-to-child transmission (PMTCT) programme. As a result, a call for stronger linkages between sexual and reproductive health and HIV policies, programmes and services has been issued by several international organizations. However, implementers of PMTCT and other HIV programmes have been constrained in translating these goals into practice. The obstacles include: (i) the narrow focus of current PMTCT programmes on treating HIV-positive women who are already pregnant; (ii) separate, parallel funding mechanisms for sexual and reproductive health and HIV programmes; (iii) political resistance from major HIV funders and policy-makers to include sexual and reproductive health as an important HIV programme component; and (iv) gaps in the evidence base regarding effective approaches for integrating sexual and reproductive health and HIV services

Are condoms the answer to rising rates of non-HIV sexually transmitted infections? Yes

Consistent condom use can reduce the spread of HIV, and Markus Steiner and Willard Cates believe condoms are the answer to other sexually transmitted infections. But Stephen Genuis argues that a more comprehensive approach is neede