HIV InfectionsPhase 1NCT00213057
Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand
A Phase 1 study testing Carraguard (PC-515) in people with HIV Infections and Chlamydia Trachomatis, run by Population Council at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Chlamydia Trachomatis, Nesseria Gonorrhea
- What is being tested?
- Carraguard (PC-515)
- How many people
- 110 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2001to Jun 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- · 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
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- 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.
Who cannot join
- · 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),
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- Genital epithelial disruption; men/women with healed lesions (intact epithelium) will be eligible,
- Untreated symptomatic bacterial vaginosis or candidiasis. Women with asymptomatic BV or yeast may be enrolled. Women with treated symptomatic BV or candidaisis may be enrolled once no longer symptomatic. Women with signs or laboratory evidence of BV or candidaisis may be enrolled if they are asymptomatic. Women with symptoms of vaginal infection may be enrolled only if their enrollment visit stat laboratory evaluation is negative for BV, candidaisis or trichomoniasis,
- Presence of balanitis. Men with resolved balanitis (e.g. through treatment) will be eligible,
- Abnormal Pap smear (Class II or above),
- History of sensitivity/allergy to latex,
- Concurrent participation in another trial of a vaginal product,
- Injection of recreational drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Trial to Assess Expanded Safety and Acceptability of Carraguard™ (PC-515) Vaginal Gel Among Heterosexual Couples in Chiang Rai
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.
Read the detailed description
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) in both men and women - including signs of local irritation, such as itching or burning; changes in vaginal flora (women); and incidence of abnormal external genital, vaginal (women), and cervical findings (women) - when applied vaginally prior to intercourse for 6 months; to evaluate acceptability; to gauge men's and women's reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.
Secondary aims were to investigate sexually transmitted infections averted - including HIV, C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications) in men and women; bacterial vaginosis and candidaisis in women; and balanitis in men; and effect on cervical cytology.
- Conditions
- HIV Infections, Chlamydia Trachomatis, Nesseria Gonorrhea, Trichomonas Vaginitis, Syphilis
- Being tested
- Carraguard (PC-515)
- Keywords
- Microbicides, HIV prevention, sexually transmitted infections, carrageenan, sero-concordant couples, HIV Seronegativity, HIV
- Medical subject headings
- HIV Infections, Trichomonas Vaginitis, Syphilis, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carraguard (PC-515)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Secondary outcomes (1)
Preliminary effectiveness: Swabs taken from women an urine specimens collected from men to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis (monthly) and for genital ulcer disease, if ulceration was detected; blood drawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2001
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Thailand, Chiang Rai Public Health Office, Chiang Rai District Health Office, Chiang Rai Municipal Health Office, Chiang Rai Hospital, Bill and Melinda Gates Foundation
- Investigators
- Kelly Blanchard, MSc, Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213057
- Sponsor's protocol ID
- Population Council #270
- Other IDs
- CDC Protocol #2968
- Status last verified
- Aug 2017
- First submitted
- 13 Sep 2005
- Last updated
- 14 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Trial to Assess Expanded Safety and Acceptability of Carraguard™ (PC-515) Vaginal Gel Among Heterosexual Couples in Chiang Rai
- ClinicalTrials.gov ID
- NCT00213057
- Acronym / sponsor ID
- Population Council #270
- Conditions
- HIV Infections, Chlamydia Trachomatis, Nesseria Gonorrhea, Trichomonas Vaginitis, Syphilis
- Keywords
- Microbicides, HIV prevention, sexually transmitted infections, carrageenan, sero-concordant couples, HIV Seronegativity, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Thailand, Chiang Rai Public Health Office, Chiang Rai District Health Office, Chiang Rai Municipal Health Office, Chiang Rai Hospital, Bill and Melinda Gates Foundation
- Study start
- Jun 2001 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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) in both men and women - including signs of local irritation, such as itching or burning; changes in vaginal flora (women); and incidence of abnormal external genital, vaginal (women), and cervical findings (women) - when applied vaginally prior to intercourse for 6 months; to evaluate acceptability; to gauge men's and women's reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.
Secondary aims were to investigate sexually transmitted infections averted - including HIV, C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications) in men and women; bacterial vaginosis and candidaisis in women; and balanitis in men; and effect on cervical cytology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- · In good health,
Key exclusion criteria (13 listed)
- · Pregnant or desire to become pregnant at time of study participation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carraguard (PC-515) | Drug | – |
Primary outcome
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).
1 secondary outcome
Preliminary effectiveness: Swabs taken from women an urine specimens collected from men to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis (monthly) and for genital ulcer disease, if ulceration was detected; blood drawn
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Blanchard, MSc principal investigator
Population Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carraguard (PC-515) in people with HIV Infections and Chlamydia Trachomatis, run by Population Council at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.