HIV InfectionsPhase 2NCT00213018
Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
A Phase 2 study testing Carraguard (PC-515) in people with HIV Infections and Chlamydia Trachomatis, run by Population Council at 2 sites in South Africa.
Trial summary
The primary aims of the study were to assess the safety and acceptability of Carraguard ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV. 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
- 400 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Oct 1999to Jan 2002
- 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 for RTIs
- 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 screening
- Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations), and,
- Able to give informed consent
Who cannot join
- Pregnant or desire to become pregnant during the trial
- Delivered or aborted a pregnancy within the six weeks prior to screening
- 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)
- Clinical suspicion of a RTI (defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STI test result)
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- Abnormal Pap smear
- History of sensitivity/allergy to latex
- Participating in another trial of a vaginal product
- Reported injection of recreational drugs
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
University of Cape Town, Department of Community Health
Cape Town, 7925
Medical University of Southern Africa
Soshanguve, 0204
About this study
Official title: A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission
The primary aims of the study were to assess the safety and acceptability of Carraguard ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; 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 efficacy 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 two sites in South Africa. The primary aims of the study were to assess Carraguard's safety (toxicity) - including signs of irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings - when applied vaginally for durations of 6-12 months, and to evaluate several dimensions of the acceptability of Carraguard and placebo products. Secondary aims were to investigate whether study participants using Carraguard had lower rates of HIV seroconversion or other sexually transmitted infections (including C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum) than the placebo (methyl cellulose gel). In addition, when it began, this trial was the first to explore the feasibility of large-scale microbicides testing in a non-sex worker population. Last, the trial gauged women's reactions to using a non-contraceptive product (in vitro testing had shown that Carraguard has no contraceptive effect), as well as potential use-dynamics in communities where drying agents and other traditional vaginal products are used with high frequency.
- Conditions
- HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae, Trichomonas Vaginitis, Syphilis
- 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, 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): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal 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 (monthly) and blood drawn for syphilis and HIV testing (Month 1 and quarterly thereafter).
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 startOct 1999
- Study completionJan 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, FHI 360, National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa, University of Cape Town, University of Limpopo, United States Agency for International Development (USAID)
- Investigators
- Charlotte E. Ellertson, MPA, Ph.D., Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213018
- Sponsor's protocol ID
- Population Council #210
- Other IDs
- R01AI045468-02
- 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 Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission
- ClinicalTrials.gov ID
- NCT00213018
- Acronym / sponsor ID
- Population Council #210
- Conditions
- HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae, Trichomonas Vaginitis, Syphilis
- 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
- 400 participants
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, FHI 360, National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa, University of Cape Town, University of Limpopo, United States Agency for International Development (USAID)
- Study start
- Oct 1999 (actual)
- Study completion
- Jan 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 ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; 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 efficacy 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 two sites in South Africa. The primary aims of the study were to assess Carraguard's safety (toxicity) - including signs of irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings - when applied vaginally for durations of 6-12 months, and to evaluate several dimensions of the acceptability of Carraguard and placebo products. Secondary aims were to investigate whether study participants using Carraguard had lower rates of HIV seroconversion or other sexually transmitted infections (including C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum) than the placebo (methyl cellulose gel). In addition, when it began, this trial was the first to explore the feasibility of large-scale microbicides testing in a non-sex worker population. Last, the trial gauged women's reactions to using a non-contraceptive product (in vitro testing had shown that Carraguard has no contraceptive effect), as well as potential use-dynamics in communities where drying agents and other traditional vaginal products are used with high frequency.
Study design
- Primary purpose
- Prevention
- 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 (6 listed)
- In good health as determined by medical history, physical examination and results of laboratory screening tests for RTIs
- 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 screening
- Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations), and,
Key exclusion criteria (10 listed)
- Pregnant or desire to become pregnant during the trial
- Delivered or aborted a pregnancy within the six weeks prior to screening
- 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)
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): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal 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 (monthly) and blood drawn for syphilis and HIV testing (Month 1 and quarterly thereafter).
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.
Charlotte E. Ellertson, MPA, Ph.D. principal investigator
Population Council
2 sites 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 2 sites in South Africa.
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 6 inclusion and 10 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 2 sites in South Africa. 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 (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal 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.