HIV Infections Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double-blind Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of PC-515 (Lambda Carrageenan) for Vaginal Use as a Possible Microbicide
The primary aims of the study were to assess the safety and acceptability of PC-515 when
applied vaginally at least three times weekly for 12 months. Secondary aims were to gather
preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of
HIV, and other STIs.
The hypothesis was that Carraguard would cause little or no significant irritation, including
lesions; and that women would find Carraguard acceptable. The study was not powered to
determine effectiveness, but based on safety, acceptability and feasibility parameters, the
outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3
trial.
Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a
triple-masked, randomized, placebo-controlled trial fielded in one site in Chiang Rai,
northern Thailand. The primary aims of the study were to assess Carraguard's safety
(toxicity) - including signs of local irritation, such as itching or burning; changes in
vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings -
when applied vaginally for 12 months; to evaluate acceptability; to assess feasibility of
conducting a large scale microbicide trial in a non-sex worker population; to gauge women's
reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a
Thai population.
Secondary aims were to investigate HIV infections averted (preliminary indications); other
sexually transmitted infections averted - including C. trachomatis, N. gonorrhoeae, T.
vaginalis, and T. pallidum (preliminary indications); and effect on cervical cytology.
;
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