HIV InfectionsPhase 2NCT00441298
Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV
A Phase 2 study testing Tenofovir gel in people with HIV Infections, run by Centre for the AIDS Programme of Research in South Africa at 2 sites in South Africa.
Trial summary
This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 889 participants
- Where
- 2 sitesSouth Africa
- Study dates
- May 2007to Mar 2010
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years (inclusive)
- Able and willing to provide written informed consent to be screened for, and to enrol in, the study.
- Able and willing to provide adequate locator information for study retention purposes.
- Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening.
- HIV negative on testing performed by study staff within 30 days of enrolment.
- Have a negative pregnancy test which was performed by study staff within 21 days of enrolment
- Agree to use a non-barrier form of contraceptive
- Agree to adhere to study visits and procedures
Who cannot join
- History of adverse reaction to latex.
- Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):
- To travel away from the study site for more than 30 consecutive days.
- To relocate away from the study site.
- To become pregnant
- To enrol in any other study of an investigational product or behaviour modification related to HIV prevention.
Show all 12Show fewer
- Has a creatinine clearance <50ml/min, as estimated using the method of Cockcroft and Gault(33).
- Has active Hepatitis B infection (since January 2009)
- Has a clinically apparent pelvic examination finding (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.
- Has in the past year participated in any research related to any vaginally applied product/s.
- Has current STI symptoms and/or other reproductive tract infection requiring treatment, as assessed by study staff. Otherwise eligible participants diagnosed during screening with infection(s) requiring treatment may be enrolled provided that treatment has commenced.
- Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, 4001
CAPRISA, Vulindlela Clinical Research Site
Pietermaritzburg, KwaZulu-Natal, 4013
About this study
Official title: Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.
Read the detailed description
Purpose: To assess the safety and effectiveness of tenofovir gel, a candidate vaginal microbicide, in sexually active women at risk for human immunodeficiency virus (HIV) infection in South Africa.
Design: Phase IIb, two-arm, double-blind, randomised, controlled trial comparing 1% tenofovir gel with a placebo gel.
Study Population: Sexually active, HIV-uninfected women aged 18 to 40 years in South Africa
Study Size: 900 women
Treatment Regimen: Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel or placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
Study Duration: Approximately 30 months in total. Accrual will require approximately 14 months and follow-up will continue until 92 incident HIV infections are observed in the study, which is expected to occur approximately 16 months after the end of the accrual period.
Primary Objective:
To evaluate the effectiveness and safety of a candidate vaginal microbicide, tenofovir gel, when applied intravaginally by women, in preventing sexually transmitted HIV infection.
Secondary Objectives:
- To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption
- To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial.
- To assess tenofovir resistance in HIV seroconvertors in the trial
- To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes
- To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance
Ancillary Objective
•To assess the impact, if any, of tenofovir gel in preventing sexually transmitted infections, including herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV) infections.
Study sites:
- CAPRISA Vulindlela Clinical Research Site, KwaZulu-Natal, South Africa
- CAPRISA eThekwini Clinical Research Site, Durban, South Africa
- Conditions
- HIV Infections
- Being tested
- Tenofovir gel, Placebo (Universal HEC placebo)
- Keywords
- microbicides, safety, effectiveness, Tenofovir gel, HIV, young women, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir gelDrug
Also called Tenofovir = Viread
Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
Placebo (Universal HEC placebo)Drug
Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tenofovir gel (a reverse transcriptase inhibitor) Receives: Drug: Tenofovir gel |
| 2 | Placebo comparator | Universal HEC placebo Receives: Drug: Placebo (Universal HEC placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV status compared between arms (tenofovir vs placebo)
The effectiveness of tenofovir against HIV infection will be measured by comparing the incidence of HIV in the tenofovir arm with that in the placebo arm
Measured: Baseline and monthly HIV testing for the duration of the study, an expected average of 18 months
Secondary outcomes (6)
Change in incidence rate of deep epithelial disruption compared between arms
To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption
Measured: Baseline and monthly assessments for the duration of the study, an expected average of 18 months
To assess the impact of tenofovir gel on viral load
To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial.
Measured: measured at the first visit post HIV infection, and again 3 months later
To assess tenofovir resistance in HIV seroconvertors in the trial
Measured: performed at the post-seroconversion visit
To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes
Measured: Assessed at baseline and monthly for the duration of the study, an expected average of 18 months
To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance
Assess new HIV seroconversions in the period between study exit and the post study visit (range 2 to 4 months)
Measured: Assessed at post study visit
Impact of tenofovir gel on other sexually transmitted infections
To assess the impact, if any, of tenofovir gel in preventing sexually transmitted infections, including herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV) infections
Measured: Change from baseline to study exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Sponsor type
- Research network
- Collaborators
- FHI 360, United States Agency for International Development (USAID), CONRAD
- Responsible party
- Principal investigator, Dr Salim S Abdool Karim, Centre for the AIDS Programme of Research in South Africa
- Investigators
- Salim S Abdool karim, MBChB, PhD, Principal investigator, CAPRISA, University of KwaZulu-NatalQuarraisha Abdool Karim, PhD, Principal investigator, CAPRISA, University of KwaZulu-Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441298
- Sponsor's protocol ID
- CAPRISA 004
- Other IDs
- PHSC study #9946
- Status last verified
- Jan 2016
- First submitted
- 27 Feb 2007
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3.
PubMed 16470118Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.
PubMed 20643915Wang Y, Noel-Romas L, Perner M, Knodel S, Molatlhegi R, Hoger S, Birse K, Zuend CF, McKinnon LR, Burgener AD. Non-Lactobacillus-Dominant and Polymicrobial Vaginal Microbiomes Are More Common in Younger South African Women and Predictive of Increased Risk of Human Immunodeficiency Virus Acquisition. Clin Infect Dis. 2023 Apr 17;76(8):1372-1381. doi: 10.1093/cid/ciac938.
PubMed 36504254Abdool Karim SS, Abdool Karim Q, Kharsany AB, Baxter C, Grobler AC, Werner L, Kashuba A, Mansoor LE, Samsunder N, Mindel A, Gengiah TN; CAPRISA 004 Trial Group. Tenofovir Gel for the Prevention of Herpes Simplex Virus Type 2 Infection. N Engl J Med. 2015 Aug 6;373(6):530-9. doi: 10.1056/NEJMoa1410649.
PubMed 26244306Naranbhai V, Samsunder N, Sandler NG, Roque A, Abdool Karim Q, Ndung'u T, Carr WH, Altfeld M, Douek DC, Abdool Karim SS; CAPRISA 004 Trial Team. Neither microbial translocation nor TLR responsiveness are likely explanations for preexisting immune activation in women who subsequently acquired HIV in CAPRISA 004. J Acquir Immune Defic Syndr. 2013 Jul 1;63(3):294-8. doi: 10.1097/QAI.0b013e31828e604b.
PubMed 23481666Matthews LT, Sibeko S, Mansoor LE, Yende-Zuma N, Bangsberg DR, Karim QA. Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial. PLoS One. 2013;8(3):e56400. doi: 10.1371/journal.pone.0056400. Epub 2013 Mar 5.
PubMed 23472071Naranbhai V, Altfeld M, Abdool Karim Q, Ndung'u T, Abdool Karim SS, Carr WH; Centre for the AIDS Programme of Research in South Africa (CAPRISA) Tenofovir gel Research for AIDS Prevention Science (TRAPS) Team. Natural killer cell function in women at high risk for HIV acquisition: insights from a microbicide trial. AIDS. 2012 Sep 10;26(14):1745-53. doi: 10.1097/QAD.0b013e328357724f.
PubMed 22781225Karim QA, Kharsany AB, Frohlich JA, Baxter C, Yende N, Mansoor LE, Mlisana KP, Maarschalk S, Arulappan N, Grobler A, Sibeko S, Omar Z, Gengiah TN, Mlotshwa M, Samsunder N, Karim SS. Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial. Trials. 2011 Mar 7;12:67. doi: 10.1186/1745-6215-12-67.
PubMed 21385354
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
- ClinicalTrials.gov ID
- NCT00441298
- Acronym / sponsor ID
- CAPRISA 004
- Conditions
- HIV Infections
- Keywords
- microbicides, safety, effectiveness, Tenofovir gel, HIV, young women, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 889 participants (actual)
- Lead sponsor
- Centre for the AIDS Programme of Research in South AfricaResearch network
- Collaborators
- FHI 360, United States Agency for International Development (USAID), CONRAD
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Feb 2007 (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.
This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.
Detailed description
Purpose: To assess the safety and effectiveness of tenofovir gel, a candidate vaginal microbicide, in sexually active women at risk for human immunodeficiency virus (HIV) infection in South Africa.
Design: Phase IIb, two-arm, double-blind, randomised, controlled trial comparing 1% tenofovir gel with a placebo gel.
Study Population: Sexually active, HIV-uninfected women aged 18 to 40 years in South Africa
Study Size: 900 women
Treatment Regimen: Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel or placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
Study Duration: Approximately 30 months in total. Accrual will require approximately 14 months and follow-up will continue until 92 incident HIV infections are observed in the study, which is expected to occur approximately 16 months after the end of the accrual period.
Primary Objective:
To evaluate the effectiveness and safety of a candidate vaginal microbicide, tenofovir gel, when applied intravaginally by women, in preventing sexually transmitted HIV infection.
Secondary Objectives:
- To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption
- To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial.
- To assess tenofovir resistance in HIV seroconvertors in the trial
- To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes
- To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance
Ancillary Objective
•To assess the impact, if any, of tenofovir gel in preventing sexually transmitted infections, including herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV) infections.
Study sites:
- CAPRISA Vulindlela Clinical Research Site, KwaZulu-Natal, South Africa
- CAPRISA eThekwini Clinical Research Site, Durban, South Africa
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tenofovir gelTenofovir gel (a reverse transcriptase inhibitor) |
| 2 | Placebo comparator | Drug: Placebo (Universal HEC placebo)Universal HEC placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-40 years (inclusive)
- Able and willing to provide written informed consent to be screened for, and to enrol in, the study.
- Able and willing to provide adequate locator information for study retention purposes.
- Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening.
- HIV negative on testing performed by study staff within 30 days of enrolment.
Key exclusion criteria (12 listed)
- History of adverse reaction to latex.
- Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):
- Has a creatinine clearance <50ml/min, as estimated using the method of Cockcroft and Gault(33).
- Has active Hepatitis B infection (since January 2009)
- Has a clinically apparent pelvic examination finding (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.
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 |
|---|---|---|
| Tenofovir gelAlso: Tenofovir = VireadParticipants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period. | Drug | 1 |
| Placebo (Universal HEC placebo)Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period. | Drug | 2 |
Primary outcome
Change in HIV status compared between arms (tenofovir vs placebo)
Time frame: Baseline and monthly HIV testing for the duration of the study, an expected average of 18 months
The effectiveness of tenofovir against HIV infection will be measured by comparing the incidence of HIV in the tenofovir arm with that in the placebo arm
6 secondary outcomes
Change in incidence rate of deep epithelial disruption compared between arms
Time frame: Baseline and monthly assessments for the duration of the study, an expected average of 18 months
To assess the impact of tenofovir gel on viral load
Time frame: measured at the first visit post HIV infection, and again 3 months later
To assess tenofovir resistance in HIV seroconvertors in the trial
Time frame: performed at the post-seroconversion visit
To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes
Time frame: Assessed at baseline and monthly for the duration of the study, an expected average of 18 months
To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance
Time frame: Assessed at post study visit
Impact of tenofovir gel on other sexually transmitted infections
Time frame: Change from baseline to study exit
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 1 Feb 2016.
- Background: PubMed 16470118Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3.
- Results publication: PubMed 20643915Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.
- Derived from this study: PubMed 36504254Wang Y, Noel-Romas L, Perner M, Knodel S, Molatlhegi R, Hoger S, Birse K, Zuend CF, McKinnon LR, Burgener AD. Non-Lactobacillus-Dominant and Polymicrobial Vaginal Microbiomes Are More Common in Younger South African Women and Predictive of Increased Risk of Human Immunodeficiency Virus Acquisition. Clin Infect Dis. 2023 Apr 17;76(8):1372-1381. doi: 10.1093/cid/ciac938.
- Derived from this study: PubMed 26244306Abdool Karim SS, Abdool Karim Q, Kharsany AB, Baxter C, Grobler AC, Werner L, Kashuba A, Mansoor LE, Samsunder N, Mindel A, Gengiah TN; CAPRISA 004 Trial Group. Tenofovir Gel for the Prevention of Herpes Simplex Virus Type 2 Infection. N Engl J Med. 2015 Aug 6;373(6):530-9. doi: 10.1056/NEJMoa1410649.
- Derived from this study: PubMed 23481666Naranbhai V, Samsunder N, Sandler NG, Roque A, Abdool Karim Q, Ndung'u T, Carr WH, Altfeld M, Douek DC, Abdool Karim SS; CAPRISA 004 Trial Team. Neither microbial translocation nor TLR responsiveness are likely explanations for preexisting immune activation in women who subsequently acquired HIV in CAPRISA 004. J Acquir Immune Defic Syndr. 2013 Jul 1;63(3):294-8. doi: 10.1097/QAI.0b013e31828e604b.
- Derived from this study: PubMed 23472071Matthews LT, Sibeko S, Mansoor LE, Yende-Zuma N, Bangsberg DR, Karim QA. Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial. PLoS One. 2013;8(3):e56400. doi: 10.1371/journal.pone.0056400. Epub 2013 Mar 5.
- Derived from this study: PubMed 22781225Naranbhai V, Altfeld M, Abdool Karim Q, Ndung'u T, Abdool Karim SS, Carr WH; Centre for the AIDS Programme of Research in South Africa (CAPRISA) Tenofovir gel Research for AIDS Prevention Science (TRAPS) Team. Natural killer cell function in women at high risk for HIV acquisition: insights from a microbicide trial. AIDS. 2012 Sep 10;26(14):1745-53. doi: 10.1097/QAD.0b013e328357724f.
- Derived from this study: PubMed 21385354Karim QA, Kharsany AB, Frohlich JA, Baxter C, Yende N, Mansoor LE, Mlisana KP, Maarschalk S, Arulappan N, Grobler A, Sibeko S, Omar Z, Gengiah TN, Mlotshwa M, Samsunder N, Karim SS. Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial. Trials. 2011 Mar 7;12:67. doi: 10.1186/1745-6215-12-67.
- Central website for the Centre for the AIDS Programme of Research in South AfricaLink 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.
Salim S Abdool karim, MBChB, PhD principal investigator
CAPRISA, University of KwaZulu-Natal
Quarraisha Abdool Karim, PhD principal investigator
CAPRISA, University of KwaZulu-Natal
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 Tenofovir gel in people with HIV Infections, run by Centre for the AIDS Programme of Research in South Africa 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 8 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 1 Feb 2016. 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. Some participants in this study may receive a placebo. 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?
Change in HIV status compared between arms (tenofovir vs placebo) (time frame: Baseline and monthly HIV testing for the duration of the study, an expected average of 18 months). 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 NCT00441298, which also lists 8 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 1 Feb 2016.