title: Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.
abstract: OBJECTIVE
  To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male-to-female HIV transmission.
  
  
  METHODS
  Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open-label no gel arm.
  
  
  METHODS
  Study participants from Malawi, South Africa, Zambia, Zimbabwe, and the USA were instructed to apply study gel up to 1 h before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up.
  
  
  RESULTS
  The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 gel, BufferGel, placebo gel, and no gel arms were 2.70, 4.14, 3.91, and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 gel arm was lower than the placebo gel arm (hazard ratio = 0.7, P = 0.10) and the no gel arm (hazard ratio = 0.67, P = 0.06). HIV incidence rates were similar in the BufferGel and both placebo gel (hazard ratio = 1.10, P = 0.63) and no gel control arms (hazard ratio = 1.05, P = 0.78). HIV incidence was similar in the placebo gel and no gel arms (hazard ratio = 0.97, P = 0.89).
  
  
  CONCLUSIONS
  The 0.5% PRO2000 gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the Microbicide Development Programme (MDP) 301 trial have confirmed that 0.5% PRO2000 gel has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were well tolerated.
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Congella, South Africa. caprisa@ukzn.ac.za
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
authors.forename: Barbra A
authors.initials: BA
authors.lastname: Richardson
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.forename: Irving F
authors.initials: IF
authors.lastname: Hoffman
authors.forename: Zvavahera M
authors.initials: ZM
authors.lastname: Chirenje
authors.forename: Taha
authors.initials: T
authors.lastname: Taha
authors.forename: Muzala
authors.initials: M
authors.lastname: Kapina
authors.forename: Lisa
authors.initials: L
authors.lastname: Maslankowski
authors.forename: Anne
authors.initials: A
authors.lastname: Coletti
authors.forename: Albert
authors.initials: A
authors.lastname: Profy
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Moench
authors.forename: Estelle
authors.initials: E
authors.lastname: Piwowar-Manning
authors.forename: Benoît
authors.initials: B
authors.lastname: Mâsse
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hillier
authors.forename: Lydia
authors.initials: L
authors.lastname: Soto-Torres
mesh_terms: D000180:Acrylic Resins / Q000008:administration & dosage* / Q000009:adverse effects; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000349:Africa / Q000453:epidemiology; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015153:Blotting, Western; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D008875:Middle Aged; D009282:Naphthalenesulfonates / Q000008:administration & dosage* / Q000009:adverse effects; D011108:Polymers / Q000008:administration & dosage* / Q000009:adverse effects; D012725:Sexual Behavior; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000180:Acrylic Resins; D000890:Anti-Infective Agents; C420918:BufferGel; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers