HIV InfectionsPhase 2NCT00213031
Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
A Phase 2 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 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae
- What is being tested?
- Carraguard (PC-515)
- How many people
- 165 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2000to Dec 2001
- Phase
- Phase 2
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good health as determined by medical history, physical examination and results of laboratory screening tests
- Aged 18 years or older
- Resident in the area for at least one year and planning to stay for at least 12 months
- HIV-seronegative at baseline
- Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations)
- Able to achieve a score of 80% or better on true-false test of key study concepts
- Able to give informed consent
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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- Clinical suspicion of a reproductive tract infection (RTI), defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STD result (Women could be enrolled after treatment of identified RTI. Women with persistent genital epithelial disruption, i.e., ulcer, abrasion or fissure, were not eligible.
- Women with other persistent abnormal signs, such as vaginal or cervical discharge, despite treatment of identified RTI, were 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, 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.
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) - 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.
- Conditions
- HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae, Trichomonas Vaginitis, Syphilis, Herpes Simplex
- Being tested
- Carraguard (PC-515)
- Keywords
- microbicides, HIV prevention, sexually transmitted infections, female-initiated protection, carrageenan, expanded safety trial, HIV Seronegativity, HIV
- Medical subject headings
- HIV Infections, Trichomonas Vaginitis, Syphilis, Herpes Simplex, 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: Genital exam & interview for symptoms after 14 days & monthly thereafter; colposcopy done throughout trial at clinicians' discretion; monthly testing to detect changes in vagina flora.
Compliance: collection of applicators and interview(monthly)
Acceptability: interview (quarterly)
Secondary outcomes (1)
Preliminary effectiveness: Swabs taken to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis and for genital ulcer disease, if ulceration was detected; blood drawn for syphilis and HIV testing and for HSV-2 Pap smear to det
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 startFeb 2000
- Study completionDec 2001
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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 165 participants
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention-Surveillance & Epidemiology, National Center for Infectious Diseases, Ministry of Health, Thailand, Collaboration (TUC), Chiang Rai Public Health Office, Chiang Rai District Health Office, Chiang Rai Municipal Health Office, Chiang Rai Hospital
- Investigators
- Janneke HMM van de Wijgert, Ph.D., Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213031
- Sponsor's protocol ID
- Population Council #271
- Other IDs
- CDC & Prevention #2485
- 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, Acceptability and Preliminary Effectiveness of PC-515 (Lambda Carrageenan) for Vaginal Use as a Possible Microbicide
- ClinicalTrials.gov ID
- NCT00213031
- Acronym / sponsor ID
- Population Council #271
- Conditions
- HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae, Trichomonas Vaginitis, Syphilis, Herpes Simplex
- Keywords
- microbicides, HIV prevention, sexually transmitted infections, female-initiated protection, carrageenan, expanded safety trial, HIV Seronegativity, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention-Surveillance & Epidemiology, National Center for Infectious Diseases, Ministry of Health, Thailand, Collaboration (TUC), Chiang Rai Public Health Office, Chiang Rai District Health Office, Chiang Rai Municipal Health Office, Chiang Rai Hospital
- Study start
- Feb 2000 (actual)
- Study completion
- Dec 2001 (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 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.
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) - 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In good health as determined by medical history, physical examination and results of laboratory screening tests
- Aged 18 years or older
- Resident in the area for at least one year and planning to stay for at least 12 months
- HIV-seronegative at baseline
- Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations)
Key exclusion criteria (12 listed)
- 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
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: Genital exam & interview for symptoms after 14 days & monthly thereafter; colposcopy done throughout trial at clinicians' discretion; monthly testing to detect changes in vagina flora.
Compliance: collection of applicators and interview(monthly)
Acceptability: interview (quarterly)
1 secondary outcome
Preliminary effectiveness: Swabs taken to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis and for genital ulcer disease, if ulceration was detected; blood drawn for syphilis and HIV testing and for HSV-2 Pap smear to det
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.
Janneke HMM van de Wijgert, Ph.D. 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 2 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 7 inclusion and 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Genital exam & interview for symptoms after 14 days & monthly thereafter; colposcopy done throughout trial at clinicians' discretion; monthly testing to detect changes in vagina flora.. The study lists 3 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.