Publication Date:
2010-07-21
Description:
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.〈br /〉〈br /〉〈a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001187/" target="_blank"〉〈img src="https://static.pubmed.gov/portal/portal3rc.fcgi/4089621/img/3977009" border="0"〉〈/a〉 〈a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001187/" target="_blank"〉This paper as free author manuscript - peer-reviewed and accepted for publication〈/a〉〈br /〉〈br /〉〈span class="detail_caption"〉Notes: 〈/span〉Abdool Karim, Quarraisha -- Abdool Karim, Salim S -- Frohlich, Janet A -- Grobler, Anneke C -- Baxter, Cheryl -- Mansoor, Leila E -- Kharsany, Ayesha B M -- Sibeko, Sengeziwe -- Mlisana, Koleka P -- Omar, Zaheen -- Gengiah, Tanuja N -- Maarschalk, Silvia -- Arulappan, Natasha -- Mlotshwa, Mukelisiwe -- Morris, Lynn -- Taylor, Douglas -- CAPRISA 004 Trial Group -- AI51794/AI/NIAID NIH HHS/ -- D43 TW000231/TW/FIC NIH HHS/ -- D43 TW000231-17/TW/FIC NIH HHS/ -- D43TW00231/TW/FIC NIH HHS/ -- U01 AI068619/AI/NIAID NIH HHS/ -- U01AI068633/AI/NIAID NIH HHS/ -- U01AI46749/AI/NIAID NIH HHS/ -- U19 AI051794/AI/NIAID NIH HHS/ -- U19 AI051794-05/AI/NIAID NIH HHS/ -- New York, N.Y. -- Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.〈br /〉〈span class="detail_caption"〉Author address: 〈/span〉Centre for the AIDS Program of Research in South Africa (CAPRISA), Durban 4013, South Africa. caprisa@ukzn.ac.za〈br /〉〈span class="detail_caption"〉Record origin:〈/span〉 〈a href="http://www.ncbi.nlm.nih.gov/pubmed/20643915" target="_blank"〉PubMed〈/a〉
Keywords:
Adenine/administration & dosage/adverse effects/*analogs &
;
derivatives/therapeutic use
;
Administration, Intravaginal
;
Adolescent
;
Adult
;
Anti-HIV Agents/*administration & dosage/adverse effects/therapeutic use
;
Anti-Infective Agents, Local/administration & dosage/adverse effects/therapeutic
;
use
;
Double-Blind Method
;
Drug Resistance, Viral
;
Female
;
HIV Infections/epidemiology/*prevention & control
;
HIV-1/*drug effects/physiology
;
Humans
;
Incidence
;
Organophosphonates/*administration & dosage/adverse effects/therapeutic use
;
Patient Compliance
;
Pregnancy
;
Pregnancy Outcome
;
Rural Population/statistics & numerical data
;
Sexual Behavior
;
South Africa/epidemiology
;
Tenofovir
;
Urban Population/statistics & numerical data
;
Vaginal Creams, Foams, and Jellies
;
Viral Load
;
Young Adult
Print ISSN:
0036-8075
Electronic ISSN:
1095-9203
Topics:
Biology
,
Chemistry and Pharmacology
,
Computer Science
,
Medicine
,
Natural Sciences in General
,
Physics
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