title: Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.
abstract: The Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.
authors.affiliation: Centre for the AIDS Program of Research in South Africa (CAPRISA), Durban 4013, South Africa. caprisa@ukzn.ac.za
authors.forename: Quarraisha
authors.initials: Q
authors.lastname: Abdool Karim
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
authors.forename: Janet A
authors.initials: JA
authors.lastname: Frohlich
authors.forename: Anneke C
authors.initials: AC
authors.lastname: Grobler
authors.forename: Cheryl
authors.initials: C
authors.lastname: Baxter
authors.forename: Leila E
authors.initials: LE
authors.lastname: Mansoor
authors.forename: Ayesha B M
authors.initials: AB
authors.lastname: Kharsany
authors.forename: Sengeziwe
authors.initials: S
authors.lastname: Sibeko
authors.forename: Koleka P
authors.initials: KP
authors.lastname: Mlisana
authors.forename: Zaheen
authors.initials: Z
authors.lastname: Omar
authors.forename: Tanuja N
authors.initials: TN
authors.lastname: Gengiah
authors.forename: Silvia
authors.initials: S
authors.lastname: Maarschalk
authors.forename: Natasha
authors.initials: N
authors.lastname: Arulappan
authors.forename: Mukelisiwe
authors.initials: M
authors.lastname: Mlotshwa
authors.forename: Lynn
authors.initials: L
authors.lastname: Morris
authors.forename: Douglas
authors.initials: D
authors.lastname: Taylor
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D024882:Drug Resistance, Viral; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D015497:HIV-1 / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D015994:Incidence; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010349:Patient Compliance; D011247:Pregnancy; D011256:Pregnancy Outcome; D012424:Rural Population / Q000706:statistics & numerical data; D012725:Sexual Behavior; D013019:South Africa / Q000453:epidemiology; D000068698:Tenofovir; D014505:Urban Population / Q000706:statistics & numerical data; D014622:Vaginal Creams, Foams, and Jellies; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D000891:Anti-Infective Agents, Local; D063065:Organophosphonates; D014622:Vaginal Creams, Foams, and Jellies; D000068698:Tenofovir; D000225:Adenine