title: A randomised placebo-controlled safety and acceptability trial of PRO 2000 vaginal microbicide gel in sexually active women in Uganda.
abstract: OBJECTIVE
  To determine the safety of 0.5% and 2% PRO 2000 gel in terms of local and systemic adverse events (AE) and the acceptability of gel use.
  
  
  METHODS
  A randomised placebo-controlled trial among healthy, sexually active African women aged 18-45 years. Between June 2003 and September 2004, 180 consenting women were randomly assigned to one of four groups: PRO 2000 gel (0.5% or 2%), placebo gel, or condom use only. Participants were screened for sexually transmitted infections, with HIV counselling and testing. Women randomly assigned to gel used this intravaginally twice a day for 28 days. Follow-up visits were fortnightly up to 6 weeks from enrolment, and comprised a physical examination including colposcopy, laboratory testing and questionnaire interviews.
  
  
  RESULTS
  Ten women were lost to follow-up, none due to AE. Adherence with total gel doses was 69%. Observed rates of the primary toxicity endpoints, ulceration greater than 2 x 1 cm and clinically relevant coagulation abnormalities were, for PRO 2000 0.5%: 1.6% (95% CI 0.04% to 8.5%) and 0% (97.5% CI 0% to 5.7%), and for PRO 2000 2%: 0% and 0% (97.5% CI 0% to 5.9%). Women randomly assigned to active gels did not show an increased rate of AE. Gel use had no significant effect on haematology and biochemistry results. Women found gel use highly acceptable.
  
  
  CONCLUSIONS
  Both concentrations of PRO 2000 gel were found to be safe and well tolerated. These data justified testing the gels in large-scale effectiveness trials.
authors.affiliation: MRC Uganda/UVRI Research Unit on AIDS, Entebbe, Uganda.
authors.forename: Anatoli
authors.initials: A
authors.lastname: Kamali
authors.forename: Helen
authors.initials: H
authors.lastname: Byomire
authors.forename: Catherine
authors.initials: C
authors.lastname: Muwonge
authors.forename: Julie
authors.initials: J
authors.lastname: Bakobaki
authors.forename: Clare
authors.initials: C
authors.lastname: Rutterford
authors.forename: Pius
authors.initials: P
authors.lastname: Okong
authors.forename: Albert
authors.initials: A
authors.lastname: Profy
authors.forename: Romano
authors.initials: R
authors.lastname: Byaruhanga
authors.forename: Stella
authors.initials: S
authors.lastname: Namukwaya
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.forename: Heiner
authors.initials: H
authors.lastname: Grosskurth
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Nunn
authors.forename: Charles J N
authors.initials: CJ
authors.lastname: Lacey
mesh_terms: D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D017280:Condoms / Q000706:statistics & numerical data; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D009282:Naphthalenesulfonates / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D011108:Polymers / Q000008:administration & dosage* / Q000009:adverse effects; D012749:Sexually Transmitted Diseases / Q000517:prevention & control* / Q000523:psychology; D014454:Uganda; D014622:Vaginal Creams, Foams, and Jellies; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers; D014622:Vaginal Creams, Foams, and Jellies