CompletedPhase 1

Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand

Thailand110 participantsStarted 2001-06

Plain-language summary

The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted. The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * · In good health, * Aged 18 years or older, * Resident for at least 1 year; planning to stay for at least 12 months, * HIV-seronegative and free of all other STD at initial screening exam, * No reported sex partners other than current partner for prior year and and not planning on having any other sex partners for the duration of the study, * Not using condoms routinely (\>25% of the time) in the prior year * Willing and able to comply with the study protocol (including being tested for HIV, learning the results, agreeing to partner notification if a curable STD is diagnosed, and undergoing clinical evaluations), * Able to achieve a score of 80% or better on true-false test of key study concepts, and * Able to give informed consent. * Planning to have vaginal sexual intercourse together on average at least once per week during the next six months. Exclusion Criteria: * · Pregnant or desire to become pregnant at time of study participation, * Delivered or aborted a pregnancy within the six weeks prior to screening, * Male sex partner known at enrollment to be HIV positive, * History of surgery on external genitalia, vagina or cervix in the six weeks prior to screening, * Recent history of non-menstrual vaginal bleeding with intercourse, * Clinically detectable genital abnormality (including presence of warts, or a structural or congenital abnormality), * Genital epithelial disruption; men/women with healed lesions (intac…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety (toxicity/local irritation): Genital exam and interview for signs and symptoms, 14-days after enrollment and monthly thereafter for 6 months; testing for bacterial vaginosis and candida (women) and balanitis (men) monthly.

Acceptability: Interview about gel use to assess compliance (monthly) and acceptability (quarterly).

Trial details

NCT IDNCT00213057

SponsorPopulation Council

Sponsor typeOTHER

Study typeINTERVENTIONAL

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