Antiretroviral Treatment OutcomesTOASTNCT01387022
Trial to Assess the Impact of PrEP to Tenofovir Gel on the Efficacy of Tenofovir-containing ART on Viral Suppression
A study testing Tenofovir, lamivudine and efavirenz in people with Antiretroviral Treatment Outcomes, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
Trial summary
The HIV/AIDS pandemic remains among the investigators greatest public health challenges. In the absence of an effective vaccine, focus has shifted to other prevention strategies such as pre-exposure prophylaxis. 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
- Antiretroviral Treatment Outcomes
- What is being tested?
- Tenofovir, lamivudine and efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older
- Previously enrolled in the CAPRISA 004 or CAPRISA 008 study - placebo or active arms
- Able and willing to provide informed consent to be screened for, and to enrol in, the study
- Able and willing to provide adequate locator information for study retention purposes
- Confirmed HIV infection in the CAPRISA 004 or 008 trial
- Agree to adhere to study visits and procedures
Who cannot join
- Currently on antiretroviral therapy (including PMTCT prophylaxis)
- 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
1 site in 1 country.
About this study
Official title: Open Label Randomized Controlled Trial to Assess the Impact of Prophylactic Exposure to Tenofovir Gel on the Efficacy of Subsequent Tenofovir-containing Antiretroviral Therapy on Viral Suppression
The HIV/AIDS pandemic remains among the investigators greatest public health challenges. In the absence of an effective vaccine, focus has shifted to other prevention strategies such as pre-exposure prophylaxis. Tenofovir, with potent activity against retroviruses [1], was developed for oral use as Viread®, which is widely used for HIV treatment. The efficacy of Viread® has been demonstrated in treatment-experienced and naïve patients [2,3]. In antiretroviral-naive patients, the combination of tenofovir with lamivudine and efavirenz has been classified as a preferred regimen in the Department of Health and Human Services treatment guidelines[4], and has been adopted by the South African Department of health as the first line regimen in treatment-naïve HIV infected patients since April 2010. The durability of antiviral response, favourable resistance profile, once daily dosing, and excellent long term safety profile of tenofovir [5], makes this drug an attractive option in both treatment and prevention regimens and its long half-life [6], made it an ideal choice as the first antiretroviral drug to be formulated as a microbicide gel.
The CAPRISA 004 study conducted in South Africa which tested the effectiveness and safety of 1% tenofovir gel showed that the use of tenofovir in a gel formulation reduced HIV acquisition by 39% overall, and by 54% in women with high gel adherence [7]. There have been concerns raised regarding the use of tenofovir in both PrEP and treatment regimens due to the potential for selection of viral mutations and development of resistance in patients who have become HIV-infected while on PrEP.
Read more
There have been no studies conducted to determine whether using tenofovir in pre-exposure prophylaxis affects treatment outcomes in patients who later use tenofovir, which is part of the first line ART of South Africa.
This study aims to determine whether prophylactic exposure to tenofovir gel alters the therapeutic response to a tenofovir containing antiretroviral regimen.
Read the detailed description
Purpose:
To determine whether prophylactic exposure to tenofovir gel alters the therapeutic response to a tenofovir containing antiretroviral regimen
Study design:
Open label, two-arm, randomised controlled trial
Study population:
Women who become infected with HIV while participating in the CAPRISA 004 and CAPRISA 008 trials. There are 3 study populations:
Study population 1:
HIV positive women from the CAPRISA 004 tenofovir gel arm and HIV positive women from the clinical trial tenofovir gel provision arm of CAPRISA 008
Study population 2:
HIV positive women in the placebo arm of CAPRISA 004
Study population 3:
HIV positive women from the family planning service arm of CAPRISA 008
Study sites:
CAPRISA eThekwini and CAPRISA Vulindlela clinics.
Study duration:
3 years
Study intervention:
Enrolled women will be initiated on their assigned antiretroviral therapy regimen when they reach any of the following criteria:
- reach a CD4+ count of less than 350 cell/mm3
- acquire an AIDS defining illness
- become pregnant - women in any of the three study populations who become pregnant during follow-up will be initiated on their assigned treatment regimen, as appropriate, for prevention of mother-to-child transmission of HIV.
At enrolment women in each of the three study populations will be assigned randomly to one of the two following antiretroviral regimens Intervention Arm: Tenofovir, lamivudine and efavirenz Control arm: Zidovudine, lamivudine and efavirenz
Sample size: The projected sample size is 90 women. The number of women in each stratum is as follows:
Study population 1: n = 40 Study population 2: n = 30 Study population 3: n = 20
Primary endpoint:
The primary endpoint is the antiretroviral treatment failure rate at 12 months. Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death
Secondary Endpoints:
- Change in CD4+ cell count from the earliest post-infection timepoint to the time of randomisation to 12, 24 and 36 months post-randomisation
- Tenofovir resistance, defined as presence of K65R, K70E or any of the TAMS mutations.
- Reported adverse events with severity grades 3 and 4 based on the DAIDS toxicity grading tables
- Cellular and humoral immune responses
- Genital viral shedding (viral load on tear flow) Ancillary Endpoint Mother-to-child HIV transmission rates as determined by PCR on infant at 6 weeks.
- Conditions
- Antiretroviral Treatment Outcomes
- Being tested
- Tenofovir, lamivudine and efavirenz
- Keywords
- Antiretroviral treatment, Tenofovir, Drug resistance, Treatment outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir, lamivudine and efavirenzDrug
Tenofovir, 300mg daily, lifelong Lamivudine, 300mg daily, lifelong Efavirenz, 600mg daily, lifelong
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir, lamivudine and efavirenz | Experimental | Not described Receives: Drug: Tenofovir, lamivudine and efavirenz |
| Zidovudine, lamivudine and efavirenz | Active comparator | Not described Receives: Drug: Tenofovir, lamivudine and efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Antiretroviral Treatment Failure Rate at 12 Months.
Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death
Measured: 12 months post ART intiation or until time of death
Secondary outcomes (5)
Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation
Difference between 12 months and randomisation CD4+ count was calculated and then summarised
Measured: Measured at 12 months post ART initiation
Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations
Measured: From randomisation until either time of termination or time of death
Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables
Measured: From randomisation until either time of termination or time of death
Cellular and Humoral Immune Responses
We will assess whether exposure to tenofovir gel at the time of HIV acquisition alters the subsequent humoral and cellular immune responses following antiretroviral treatment initiation
Measured: 3 years
Genital Viral Shedding (Viral Load on Tear Flow)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Antiretroviral Treatment OutcomesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dr Salim S Abdool Karim, Centre for the AIDS Programme of Research in South Africa
- Investigators
- Nivashnee Naicker, MBChB, Principal investigator, Centre for the AIDS Programme of Research in South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387022
- Sponsor's protocol ID
- CAPRISA 009
- Acronym
- TOAST
- Status last verified
- Mar 2017
- First submitted
- 21 Jun 2011
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
De Clercq E. Acyclic nucleoside phosphonates: past, present and future. Bridging chemistry to HIV, HBV, HCV, HPV, adeno-, herpes-, and poxvirus infections: the phosphonate bridge. Biochem Pharmacol. 2007 Apr 1;73(7):911-22. doi: 10.1016/j.bcp.2006.09.014. Epub 2006 Sep 19.
PubMed 17045247Schooley RT, Ruane P, Myers RA, Beall G, Lampiris H, Berger D, Chen SS, Miller MD, Isaacson E, Cheng AK; Study 902 Team. Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study. AIDS. 2002 Jun 14;16(9):1257-63. doi: 10.1097/00002030-200206140-00008.
PubMed 12045491Squires K, Pozniak AL, Pierone G Jr, Steinhart CR, Berger D, Bellos NC, Becker SL, Wulfsohn M, Miller MD, Toole JJ, Coakley DF, Cheng A; Study 907 Team. Tenofovir disoproxil fumarate in nucleoside-resistant HIV-1 infection: a randomized trial. Ann Intern Med. 2003 Sep 2;139(5 Pt 1):313-20. doi: 10.7326/0003-4819-139-5_part_1-200309020-00006.
PubMed 12965939Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. December 1, 2009. Available from: www.aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Accessed 9 November 2010.
Gallant JE, Staszewski S, Pozniak AL, DeJesus E, Suleiman JM, Miller MD, Coakley DF, Lu B, Toole JJ, Cheng AK; 903 Study Group. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA. 2004 Jul 14;292(2):191-201. doi: 10.1001/jama.292.2.191.
PubMed 15249568Rohan LC, Moncla BJ, Kunjara Na Ayudhya RP, Cost M, Huang Y, Gai F, Billitto N, Lynam JD, Pryke K, Graebing P, Hopkins N, Rooney JF, Friend D, Dezzutti CS. In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide. PLoS One. 2010 Feb 19;5(2):e9310. doi: 10.1371/journal.pone.0009310.
PubMed 20174579Abdool 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 20643915Naicker N, Naidoo A, Werner L, Garrett N, Majola N, Asari V, Baxter C, Grobler A, Karim QA, Karim SSA. Efficacy and safety of tenofovir-containing antiretroviral therapy in women who acquired HIV while enrolled in tenofovir gel prophylaxis trials. Antivir Ther. 2017;22(4):287-293. doi: 10.3851/IMP3106. Epub 2016 Nov 4.
PubMed 27835613
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Controlled Trial to Assess the Impact of Prophylactic Exposure to Tenofovir Gel on the Efficacy of Subsequent Tenofovir-containing Antiretroviral Therapy on Viral Suppression
- ClinicalTrials.gov ID
- NCT01387022
- Acronym / sponsor ID
- TOAST / CAPRISA 009
- Conditions
- Antiretroviral Treatment Outcomes
- Keywords
- Antiretroviral treatment, Tenofovir, Drug resistance, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre for the AIDS Programme of Research in South AfricaResearch network
- Study start
- Jun 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The HIV/AIDS pandemic remains among the investigators greatest public health challenges. In the absence of an effective vaccine, focus has shifted to other prevention strategies such as pre-exposure prophylaxis. Tenofovir, with potent activity against retroviruses [1], was developed for oral use as Viread®, which is widely used for HIV treatment. The efficacy of Viread® has been demonstrated in treatment-experienced and naïve patients [2,3]. In antiretroviral-naive patients, the combination of tenofovir with lamivudine and efavirenz has been classified as a preferred regimen in the Department of Health and Human Services treatment guidelines[4], and has been adopted by the South African Department of health as the first line regimen in treatment-naïve HIV infected patients since April 2010. The durability of antiviral response, favourable resistance profile, once daily dosing, and excellent long term safety profile of tenofovir [5], makes this drug an attractive option in both treatment and prevention regimens and its long half-life [6], made it an ideal choice as the first antiretroviral drug to be formulated as a microbicide gel.
The CAPRISA 004 study conducted in South Africa which tested the effectiveness and safety of 1% tenofovir gel showed that the use of tenofovir in a gel formulation reduced HIV acquisition by 39% overall, and by 54% in women with high gel adherence [7]. There have been concerns raised regarding the use of tenofovir in both PrEP and treatment regimens due to the potential for selection of viral mutations and development of resistance in patients who have become HIV-infected while on PrEP.
There have been no studies conducted to determine whether using tenofovir in pre-exposure prophylaxis affects treatment outcomes in patients who later use tenofovir, which is part of the first line ART of South Africa.
This study aims to determine whether prophylactic exposure to tenofovir gel alters the therapeutic response to a tenofovir containing antiretroviral regimen.
Detailed description
Purpose:
To determine whether prophylactic exposure to tenofovir gel alters the therapeutic response to a tenofovir containing antiretroviral regimen
Study design:
Open label, two-arm, randomised controlled trial
Study population:
Women who become infected with HIV while participating in the CAPRISA 004 and CAPRISA 008 trials. There are 3 study populations:
Study population 1:
HIV positive women from the CAPRISA 004 tenofovir gel arm and HIV positive women from the clinical trial tenofovir gel provision arm of CAPRISA 008
Study population 2:
HIV positive women in the placebo arm of CAPRISA 004
Study population 3:
HIV positive women from the family planning service arm of CAPRISA 008
Study sites:
CAPRISA eThekwini and CAPRISA Vulindlela clinics.
Study duration:
3 years
Study intervention:
Enrolled women will be initiated on their assigned antiretroviral therapy regimen when they reach any of the following criteria:
- reach a CD4+ count of less than 350 cell/mm3
- acquire an AIDS defining illness
- become pregnant - women in any of the three study populations who become pregnant during follow-up will be initiated on their assigned treatment regimen, as appropriate, for prevention of mother-to-child transmission of HIV.
At enrolment women in each of the three study populations will be assigned randomly to one of the two following antiretroviral regimens Intervention Arm: Tenofovir, lamivudine and efavirenz Control arm: Zidovudine, lamivudine and efavirenz
Sample size: The projected sample size is 90 women. The number of women in each stratum is as follows:
Study population 1: n = 40 Study population 2: n = 30 Study population 3: n = 20
Primary endpoint:
The primary endpoint is the antiretroviral treatment failure rate at 12 months. Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death
Secondary Endpoints:
- Change in CD4+ cell count from the earliest post-infection timepoint to the time of randomisation to 12, 24 and 36 months post-randomisation
- Tenofovir resistance, defined as presence of K65R, K70E or any of the TAMS mutations.
- Reported adverse events with severity grades 3 and 4 based on the DAIDS toxicity grading tables
- Cellular and humoral immune responses
- Genital viral shedding (viral load on tear flow) Ancillary Endpoint Mother-to-child HIV transmission rates as determined by PCR on infant at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir, lamivudine and efavirenz | Experimental | Drug: Tenofovir, lamivudine and efavirenz |
| Zidovudine, lamivudine and efavirenz | Active comparator | Drug: Tenofovir, lamivudine and efavirenz |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Previously enrolled in the CAPRISA 004 or CAPRISA 008 study - placebo or active arms
- Able and willing to provide informed consent to be screened for, and to enrol in, the study
- Able and willing to provide adequate locator information for study retention purposes
- Confirmed HIV infection in the CAPRISA 004 or 008 trial
Key exclusion criteria (2 listed)
- Currently on antiretroviral therapy (including PMTCT prophylaxis)
- 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.
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, lamivudine and efavirenzTenofovir, 300mg daily, lifelong Lamivudine, 300mg daily, lifelong Efavirenz, 600mg daily, lifelong | Drug | Tenofovir, lamivudine and efavirenz, Zidovudine, lamivudine and efavirenz |
Primary outcome
The Antiretroviral Treatment Failure Rate at 12 Months.
Time frame: 12 months post ART intiation or until time of death
Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death
5 secondary outcomes
Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation
Time frame: Measured at 12 months post ART initiation
Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations
Time frame: From randomisation until either time of termination or time of death
Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables
Time frame: From randomisation until either time of termination or time of death
Cellular and Humoral Immune Responses
Time frame: 3 years
Genital Viral Shedding (Viral Load on Tear Flow)
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17045247De Clercq E. Acyclic nucleoside phosphonates: past, present and future. Bridging chemistry to HIV, HBV, HCV, HPV, adeno-, herpes-, and poxvirus infections: the phosphonate bridge. Biochem Pharmacol. 2007 Apr 1;73(7):911-22. doi: 10.1016/j.bcp.2006.09.014. Epub 2006 Sep 19.
- Background: PubMed 12045491Schooley RT, Ruane P, Myers RA, Beall G, Lampiris H, Berger D, Chen SS, Miller MD, Isaacson E, Cheng AK; Study 902 Team. Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study. AIDS. 2002 Jun 14;16(9):1257-63. doi: 10.1097/00002030-200206140-00008.
- Background: PubMed 12965939Squires K, Pozniak AL, Pierone G Jr, Steinhart CR, Berger D, Bellos NC, Becker SL, Wulfsohn M, Miller MD, Toole JJ, Coakley DF, Cheng A; Study 907 Team. Tenofovir disoproxil fumarate in nucleoside-resistant HIV-1 infection: a randomized trial. Ann Intern Med. 2003 Sep 2;139(5 Pt 1):313-20. doi: 10.7326/0003-4819-139-5_part_1-200309020-00006.
- BackgroundPanel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. December 1, 2009. Available from: www.aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Accessed 9 November 2010.
- Background: PubMed 15249568Gallant JE, Staszewski S, Pozniak AL, DeJesus E, Suleiman JM, Miller MD, Coakley DF, Lu B, Toole JJ, Cheng AK; 903 Study Group. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA. 2004 Jul 14;292(2):191-201. doi: 10.1001/jama.292.2.191.
- Background: PubMed 20174579Rohan LC, Moncla BJ, Kunjara Na Ayudhya RP, Cost M, Huang Y, Gai F, Billitto N, Lynam JD, Pryke K, Graebing P, Hopkins N, Rooney JF, Friend D, Dezzutti CS. In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide. PLoS One. 2010 Feb 19;5(2):e9310. doi: 10.1371/journal.pone.0009310.
- Background: 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 27835613Naicker N, Naidoo A, Werner L, Garrett N, Majola N, Asari V, Baxter C, Grobler A, Karim QA, Karim SSA. Efficacy and safety of tenofovir-containing antiretroviral therapy in women who acquired HIV while enrolled in tenofovir gel prophylaxis trials. Antivir Ther. 2017;22(4):287-293. doi: 10.3851/IMP3106. Epub 2016 Nov 4.
Related trials for Antiretroviral Treatment Outcomes
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Active, not recruitingPhase 3
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
HIV-1-infection, Non-Adherence, Medication
Not yet recruitingPhase 4
Sleep Outcomes and Multidimensional Sleep Assessment - a Randomized Trial of Dolutegravir- vs Doravirine-based Antiretroviral Therapy in People Living With HIV
HIV (Human Immunodeficiency Virus), Sleep
Not yet recruiting
Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.
HIV Antiretroviral Therapy (ART) Adherence, Alcohol Consumption
RecruitingObservational study
Post Analytic Treatment Interruption Study
HIV
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.
Nivashnee Naicker, MBChB principal investigator
Centre for the AIDS Programme of Research in South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir, lamivudine and efavirenz in people with Antiretroviral Treatment Outcomes, run by Centre for the AIDS Programme of Research in South Africa at 1 site 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 2 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 20 Apr 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Antiretroviral Treatment Failure Rate at 12 Months. (time frame: 12 months post ART intiation or until time of death). 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 NCT01387022, 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 20 Apr 2017.