HIV InfectionsPhase 3NCT00213083
Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
A Phase 3 study testing Carraguard (PC-515) in people with HIV Infections and AIDS, run by Population Council at 3 sites in South Africa.
Trial summary
The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, AIDS, Sexually Transmitted Diseases
- What is being tested?
- Carraguard (PC-515)
- How many people
- 6,203 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Apr 2004to Apr 2007
- Phase
- Phase 3
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV negative and agree to be tested for HIV and told their results at all visits during the study
- Aged 16 - 40 years of age
- Have had at least one vaginal intercourse within the last three months
- Willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant)
- Provide locator information to study staff throughout the trial
- Comply with all aspects of the study protocol, including random assignment to the Carraguard® plus condom or placebo plus condom arm, clinical valuations, specimen collection and testing, visit schedule and study drug regimen
Show all 9Show fewer
- Citizen or permanent resident of South Africa
- Resident for the past year and intends to reside in the catchment area of the site for the next two years
- During the study, will not use any vaginal products except tampons or those prescribed or approved by the study clinician.
Who cannot join
- Currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening
- Within four weeks of last pregnancy outcome at the time of enrolment
- Pap smear at screening is graded as carcinoma.
- Injected illicit drugs in the 12 months prior to screening
- Participating in any other clinical trial/HIV prevention study
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Empilisweni Clinic
Cape Town, 7925
Setshaba Research Clinic, University of Limpopo - Medunsa Campus
Medunsa, 0204
Isipingo Clinic
Overport, Durban, 4067
About this study
Official title: Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.
Read the detailed description
This study is designed to show if Carraguard® can protect women against HIV if it is used before sex, and is safe for long-term use.
- Being tested
- Carraguard (PC-515)
- Keywords
- Microbicide, HIV, AIDS, STIs, STDs, Efficacy, HSV, Women, South Africa, seroconversion, condom, safe-sex, vaginal intercourse, prevention, HIV Seronegativity
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, HIV Seropositivity, Safe Sex, Coitus
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.
Time to HIV seroconversion during trial participation (evaluated quarterly)
Secondary outcomes (2)
Determine long-term safety based on the incidence of sexually transmitted infections (STI), Chlamydia, gonorrhoeae, trichomoniasis, and syphilis tests and the number of adverse events and serious adverse events
Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated
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 startApr 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 6,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Pekka Lahteenmaki, MD, PhD, Principal investigator, Population Council, Center for Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213083
- Sponsor's protocol ID
- Population Council #322
- Status last verified
- Aug 2017
- First submitted
- 13 Sep 2005
- Last updated
- 15 Aug 2017
- Results posted
- No
Publications
Skoler S, Govender S, Altini L, Ahmed K, Waldron D, Myer L, Lahteenmaki P. Risks in the use of an unblinded-control group. J Infect Dis. 2005 Apr 15;191(8):1378-9; author reply 1379-80. doi: 10.1086/427833. No abstract available.
PubMed 15776387Wallace AR, Teitelbaum A, Wan L, Mulima MG, Guichard L, Skoler S, Vilakazi H, Mapula FS, Rossier J, Govender SN, Lahteenmaki P, Maguire RA, Phillips DM. Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials. Contraception. 2007 Jul;76(1):53-6. doi: 10.1016/j.contraception.2006.10.012. Epub 2007 May 11.
PubMed 17586138Singh JA, Karim SS, Karim QA, Mlisana K, Williamson C, Gray C, Govender M, Gray A. Enrolling adolescents in research on HIV and other sensitive issues: lessons from South Africa. PLoS Med. 2006 Jul;3(7):e180. doi: 10.1371/journal.pmed.0030180. Epub 2006 Apr 18.
PubMed 16608384Skoler-Karpoff S, Ramjee G, Ahmed K, Altini L, Plagianos MG, Friedland B, Govender S, De Kock A, Cassim N, Palanee T, Dozier G, Maguire R, Lahteenmaki P. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Dec 6;372(9654):1977-87. doi: 10.1016/S0140-6736(08)61842-5.
PubMed 19059048
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
- ClinicalTrials.gov ID
- NCT00213083
- Acronym / sponsor ID
- Population Council #322
- Keywords
- Microbicide, HIV, AIDS, STIs, STDs, Efficacy, HSV, Women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,203 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Bill and Melinda Gates Foundation
- Study start
- Apr 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (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 purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.
Detailed description
This study is designed to show if Carraguard® can protect women against HIV if it is used before sex, and is safe for long-term use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- HIV negative and agree to be tested for HIV and told their results at all visits during the study
- Aged 16 - 40 years of age
- Have had at least one vaginal intercourse within the last three months
- Willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant)
- Provide locator information to study staff throughout the trial
Key exclusion criteria (5 listed)
- Currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening
- Within four weeks of last pregnancy outcome at the time of enrolment
- Pap smear at screening is graded as carcinoma.
- Injected illicit drugs in the 12 months prior to screening
- Participating in any other clinical trial/HIV prevention study
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
Time to HIV seroconversion during trial participation (evaluated quarterly)
2 secondary outcomes
Determine long-term safety based on the incidence of sexually transmitted infections (STI), Chlamydia, gonorrhoeae, trichomoniasis, and syphilis tests and the number of adverse events and serious adverse events
Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated
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 15 Aug 2017.
- Background: PubMed 15776387Skoler S, Govender S, Altini L, Ahmed K, Waldron D, Myer L, Lahteenmaki P. Risks in the use of an unblinded-control group. J Infect Dis. 2005 Apr 15;191(8):1378-9; author reply 1379-80. doi: 10.1086/427833. No abstract available.
- Background: PubMed 17586138Wallace AR, Teitelbaum A, Wan L, Mulima MG, Guichard L, Skoler S, Vilakazi H, Mapula FS, Rossier J, Govender SN, Lahteenmaki P, Maguire RA, Phillips DM. Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials. Contraception. 2007 Jul;76(1):53-6. doi: 10.1016/j.contraception.2006.10.012. Epub 2007 May 11.
- Background: PubMed 16608384Singh JA, Karim SS, Karim QA, Mlisana K, Williamson C, Gray C, Govender M, Gray A. Enrolling adolescents in research on HIV and other sensitive issues: lessons from South Africa. PLoS Med. 2006 Jul;3(7):e180. doi: 10.1371/journal.pmed.0030180. Epub 2006 Apr 18.
- Derived from this study: PubMed 19059048Skoler-Karpoff S, Ramjee G, Ahmed K, Altini L, Plagianos MG, Friedland B, Govender S, De Kock A, Cassim N, Palanee T, Dozier G, Maguire R, Lahteenmaki P. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Dec 6;372(9654):1977-87. doi: 10.1016/S0140-6736(08)61842-5.
- Official website of the Population CouncilLink provided by the sponsor.
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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.
Pekka Lahteenmaki, MD, PhD principal investigator
Population Council, Center for Biomedical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carraguard (PC-515) in people with HIV Infections and AIDS, run by Population Council at 3 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 9 inclusion and 5 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 15 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 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to HIV seroconversion during trial participation (evaluated quarterly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00213083, which also lists 4 linked publications.
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 15 Aug 2017.