HIV-1-infectionNCT04050449
Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of TLD
An observational study of HIV-1-infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 14 sites in 6 countries.
Trial summary
Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- HIV-1-infection
- How many people
- 1,339 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 28 Oct 2019to 31 Mar 2023
- Phase
- Observational
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-infected adults and adolescents (>30 kg, ≥10 years of age) initiating or switching to TLD and receiving care through a President's Emergency Plan for AIDS Relief (PEPFAR)-supported treatment program.
Who may be able to join
- Receiving care at a PEPFAR-supported site.
- Documentation of HIV-1 infection acceptable to the local PEPFAR-supported program to allow ART to be initiated or continued.
- Ability and willingness of participant or legal guardian/representative to provide informed consent to participate in the study.
- Expectation that the participant will receive care within the local PEPFAR-supported program and will be able to be followed for study evaluations for at least 6 months and ideally for 36 months.
- Group 1 participants: Receipt of an NNRTI-containing first-line ART regimen from a clinic in a PEPFAR-supported country for at least 6 consecutive calendar months prior to study entry. NOTE: ART treatment gaps are allowed, but treatment gaps should not exceed 14 consecutive days in the 6 calendar months prior to study entry.
- Group 1 participants: HIV-1 RNA >1000 copies/mL obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
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- Group 2 participants: Receipt of a boosted PI-containing second-line ART regimen from a clinic in a PEPFAR-supported country for at least 6 consecutive calendar months prior to study entry. NOTE: ART treatment gaps are allowed, but treatment gaps should not exceed 14 consecutive days in the 6 calendar months prior to study entry.
- Group 2 participants: HIV-1 RNA obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
- If Group 2b reaches its enrollment target of 360 participants, the protocol team will notify sites that the following criteria will be implemented: For Group 2 participants, an HIV-1 RNA >1000 copies/mL will need to be obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry.
- If Group 2a reaches its enrollment target of 180 participants, the protocol team will notify sites that the following criteria will be implemented: For Group 2 participants, an HIV-1 RNA ≤1000 copies/mL will need to be obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry.
- Group 4 participants: No current or prior ART treatment. NOTE: Women who received ART regimens only during pregnancy and/or breastfeeding for prevention of mother-to-child transmission but who have not taken any ART drugs for at least 6 calendar months immediately prior to study entry will be allowed.
- For Group 1, 2, and 4 participants, expected initiation of TLD taken once daily within 7 days after study entry. NOTE: Group 1, 2, and 4 participants may not be on, or expected to start, RIF-containing TB treatment at the time of study entry.
- For Group 3 participants already on RIF-containing TB treatment but not on TLD at study entry, expected initiation of TLD taken once daily with an additional daily dose of DTG 50 mg. This must be started within 7 days after study entry AND within 56 days after the start of RIF-containing TB treatment. These participants may be ART-naïve, or may be switching from a first- or second-line ART regimen. NOTE: For ART-naïve participants who start RIF-containing TB treatment first and then start TLD at a later date, screening must occur within 14 days before the intended TLD start date.
- For Group 3 participants not already on RIF-containing TB treatment but already on TLD at study entry, receipt of TLD for at least 6 consecutive calendar months prior to study entry AND expected initiation of RIF-containing TB treatment within 7 days after study entry.
- For Group 3 participants not already on RIF-containing TB treatment or TLD at study entry, expected initiation of TLD and RIF-containing TB treatment within 7 days after study entry. These participants may be ART-naïve, or may be switching from a first- or second-line ART regimen.
- For Group 1 participants, HIV-1 RNA >1000 copies/mL obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
- For Group 2 participants, HIV-1 RNA obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
- If Group 2b reaches its enrollment target of 360 participants, the protocol team will notify sites that the following criteria will be implemented: For Group 2 participants, an HIV-1 RNA >1000 copies/mL will need to be obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry.
- If Group 2a reaches its enrollment target of 180 participants, the protocol team will notify sites that the following criteria will be implemented: For Group 2 participants, an HIV-1 RNA ≤1000 copies/mL will need to be obtained as part of standard of care or with a real-time test within 12 weeks prior to study entry.
Who cannot join
- Weight ≤30 kg.
- For participants already on ART in Groups 1, 2, and 3, known to have had an ART interruption encompassing the entire 14 day window (≥14 consecutive days) immediately prior to study entry.
- For Group 3, if a participant is already taking TLD at the time of study entry, HIV-1 RNA >1000 copies/mL within the past 9 months while taking TLD with no subsequent HIV-1 RNA ≤1000 copies/mL.
- Prior enrollment in any group in this study.
- For Group 3 participants, already on concomitant TLD and RIF-containing TB treatment prior to study entry.
- For Group 2 participants with HIV-1 RNA >1000 copies/mL from a host country in which treatment guidelines require a genotypic test prior to switching patients on a boosted PI-containing second-line ARV regimen to TLD, 65R RT mutation within 12 weeks prior to study entry.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
South Africa5 sites
Family Clinical Research Unit (FAM-CUR) CRS (8950)
Cape Town, West Cape, 7505
University of Cape Town Lung Institute (UCTLI) CRS (31792)
Cape Town, Western Cape, 7705
Durban Adult HIV CRS (11201)
Durban, 4013 SF
University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101)
Johannesburg, Gauteng, 2193
Soweto ACTG CRS (12301)
Johannesburg
Kenya3 sites
Moi University Clinical Research Center (MUCRC) CRS (12601)
Eldoret, 30100
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (12501)
Kericho, 20200
Kisumu Crs (31460)
Kisumu, 40100
Haiti2 sites
Les Centres GHESKIO CRS (30022)
Port-au-Prince, Bicentaire, HT-6110
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (31730)
Port-au-Prince
About this study
Official title: Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First- or Second-Line ART or With Rifampin-Containing TB Treatment: The Hakim Study
Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). The aim of this study is to observe how successful TLD is at treating HIV, in the following groups of people:
- People switching to TLD, after taking anti-HIV medication that contains a nonnucleoside reverse transcriptase inhibitor (NNRTI) drug (such as Efavirenz or Nevirapine) (Group 1).
- People switching to TLD, after taking anti-HIV medication that contains a boosted protease inhibitor (PI) drug (such as Lopinavir or Atazanavir) (Group 2).
- People taking TLD and receiving medication for TB that includes the drug rifampicin (RIF) (Group 3). These people must be starting one or both of these medications when they enter the study.
- People starting TLD who have not taken anti-HIV medication before (Group 4).
Another goal of this study is to use genetic testing of the virus (HIV) to see how often HIV is resistant to TLD. Genetic testing of the virus is one way to see if the TLD medication is not working to treat a person's HIV infection.
- Conditions
- HIV-1-infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Switch to TLD from NNRTI first-line regimen | Participants switching to TLD from a first-line regimen containing a NNRTI. These participants will be divided into two subgroups based upon their HIV-1 RNA level in a sample obtained at entry, before starting TLD. Group 1a will include participants with viremia (HIV-1 RNA >1000 copies/mL at start of TLD) and Group 1b will include participants with suppressed viral load (HIV-1 RNA ≤1000 copies/mL at start of TLD). | |
| Group 2: Switch to TLD from boosted PI second-line regimen | Participants switching to TLD from a second-line regimen containing a boosted PI. These participants will be divided into two subgroups based upon their HIV-1 RNA level in a sample obtained at entry, before starting TLD. Group 2a will include participants with viremia (HIV-1 RNA >1000 copies/mL at start of TLD) and Group 2b will include participants with suppressed viral load (HIV-1 RNA ≤1000 copies/mL at start of TLD). | |
| Group 3: Concomitant TLD and RIF-containing TB treatment | Participants initiating concomitant TLD and RIF-containing TB treatment, with an additional daily dose of dolutegravir (DTG) 50mg. For participants already on RIF-containing TB treatment when TLD treatment is started, TLD treatment must be started within 8 weeks (56 days) of the start of RIF-containing TB treatment. Group 1, 2, or 4 participants who start RIF-containing TB treatment after enrollment will have additional evaluations at the start and end of concomitant HIV and TB treatment but will not be co-enrolled in Group 3 (their additional evaluations will, however, be considered when analyzing data from Group 3). | |
| Group 4: ART-naive initiating TLD therapy | Antiretroviral therapy (ART)-naïve participants initiating therapy with TLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving virologic success at 6 months (Groups 1, 2, and 4)
Proportion of participants on TLD at 6 months achieving virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL. This will be based on the measurement closest to exactly 6 months (i.e., 183 days) after the date of start of TLD, within the window of 6 months ±3 months (specifically 92 to 274 days, inclusive).
Measured: 6 months +/- 3 months after starting TLD
Proportion of participants achieving virologic success at end of TLD and RIF-Containing TB Treatment (Group 3)
Proportion of participants achieving virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL at the end of concomitant TLD and RIF-containing TB treatment. This will be the measurement closest to the end of concomitant treatment within the window of 4 weeks (28 days) before the end to 6 months (183 days) after the end, inclusive.
Measured: 4 weeks before to 6 months after end of TLD and RIF-containing TB treatment (expect to end concomitant treatment within 12 months of study entry)
Secondary outcomes (8)
Proportion of participants achieving virologic success
Based on the FDA Snapshot algorithm modified to use the HIV-1 RNA threshold of 1000 copies/mL (instead of the usual 50 copies/mL) at 6 months, 12 months, 24 months, and 36 months after starting TLD in each of Groups, 1a, 1b, 2a, 2b, and 4; and at the end of concomitant TLD and RIF-containing TB treatment, 12 months, 24 months, and 36 months after starting concomitant TLD and RIF-containing TB treatment in Group 3.
Measured: 6 months, 12 months, 24 months, and 36 months after starting TLD
Proportion of participants with low HIV-1 RNA
Plasma HIV-1 RNA ≤1000 copies/mL
Measured: 12months, 24 months, and 36 months.
Time to confirmed virologic failure (VF)
Time to confirmed virologic failure (VF), defined as the time from start of TLD to the first HIV-1 RNA >1000 copies/mL at or after 6 months which is confirmed by the next HIV-1 RNA measurement also being >1000 copies/mL
Measured: At or after 6 months which is confirmed by the next HIV-1 RNA measurement
Time to confirmed virologic failure with a new DTG resistance-associated mutation
DTG resistance-associated mutation as detected in population-based sequencing. New is a mutation not present in the last population-based sequence obtained prior to initiating TLD).
Measured: From 0 to 36 months
Time from start of TLD to TLD discontinuation
Time from start of TLD to TLD discontinuation
Measured: From 0 to 36 months
Time from start of TLD to TLD discontinuation due to toxicity.
Time from start of TLD to TLD discontinuation due to toxicity.
Measured: From 0 to 36 months
Change in quality of life (QoL)
Change in quality of life (QoL), defined as the difference in the summary scores obtained from the ACTG SF-21 at 6 months from the scores obtained at study entry
Measured: From study start to 6 months
Time from start of TLD to first occurrence of a targeted clinical event
Time from start of TLD to first occurrence of a targeted clinical event
Measured: From 0 to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start28 Oct 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), United States President's Emergency Plan for AIDS Relief
- Responsible party
- Sponsor
- Investigators
- Cissy Kityo, MBChB; M.Sc.; Ph.D., Study chair, Joint Clinical Research Centre (JCRC)/Kampala CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050449
- Sponsor's protocol ID
- ACTG A5381
- Other IDs
- UM1AI068636
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2019
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First- or Second-Line ART or With Rifampin-Containing TB Treatment: The Hakim Study
- ClinicalTrials.gov ID
- NCT04050449
- Acronym / sponsor ID
- ACTG A5381
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,339 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), United States President's Emergency Plan for AIDS Relief
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Aug 2019 (actual)
- 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.
Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). The aim of this study is to observe how successful TLD is at treating HIV, in the following groups of people:
- People switching to TLD, after taking anti-HIV medication that contains a nonnucleoside reverse transcriptase inhibitor (NNRTI) drug (such as Efavirenz or Nevirapine) (Group 1).
- People switching to TLD, after taking anti-HIV medication that contains a boosted protease inhibitor (PI) drug (such as Lopinavir or Atazanavir) (Group 2).
- People taking TLD and receiving medication for TB that includes the drug rifampicin (RIF) (Group 3). These people must be starting one or both of these medications when they enter the study.
- People starting TLD who have not taken anti-HIV medication before (Group 4).
Another goal of this study is to use genetic testing of the virus (HIV) to see how often HIV is resistant to TLD. Genetic testing of the virus is one way to see if the TLD medication is not working to treat a person's HIV infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Switch to TLD from NNRTI first-line regimen | – | –Participants switching to TLD from a first-line regimen containing a NNRTI. These participants will be divided into two subgroups based upon their HIV-1 RNA level in a sample obtained at entry, before starting TLD. Group 1a will include participants with viremia (HIV-1 RNA >1000 copies/mL at start of TLD) and Group 1b will include participants with suppressed viral load (HIV-1 RNA ≤1000 copies/mL at start of TLD). |
| Group 2: Switch to TLD from boosted PI second-line regimen | – | –Participants switching to TLD from a second-line regimen containing a boosted PI. These participants will be divided into two subgroups based upon their HIV-1 RNA level in a sample obtained at entry, before starting TLD. Group 2a will include participants with viremia (HIV-1 RNA >1000 copies/mL at start of TLD) and Group 2b will include participants with suppressed viral load (HIV-1 RNA ≤1000 copies/mL at start of TLD). |
| Group 3: Concomitant TLD and RIF-containing TB treatment | – | –Participants initiating concomitant TLD and RIF-containing TB treatment, with an additional daily dose of dolutegravir (DTG) 50mg. For participants already on RIF-containing TB treatment when TLD treatment is started, TLD treatment must be started within 8 weeks (56 days) of the start of RIF-containing TB treatment. Group 1, 2, or 4 participants who start RIF-containing TB treatment after enrollment will have additional evaluations at the start and end of concomitant HIV and TB treatment but will not be co-enrolled in Group 3 (their additional evaluations will, however, be considered when analyzing data from Group 3). |
| Group 4: ART-naive initiating TLD therapy | – | –Antiretroviral therapy (ART)-naïve participants initiating therapy with TLD |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-infected adults and adolescents (>30 kg, ≥10 years of age) initiating or switching to TLD and receiving care through a President's Emergency Plan for AIDS Relief (PEPFAR)-supported treatment program.
Key inclusion criteria (19 listed)
- Receiving care at a PEPFAR-supported site.
- Documentation of HIV-1 infection acceptable to the local PEPFAR-supported program to allow ART to be initiated or continued.
- Ability and willingness of participant or legal guardian/representative to provide informed consent to participate in the study.
- Expectation that the participant will receive care within the local PEPFAR-supported program and will be able to be followed for study evaluations for at least 6 months and ideally for 36 months.
- Group 1 participants: Receipt of an NNRTI-containing first-line ART regimen from a clinic in a PEPFAR-supported country for at least 6 consecutive calendar months prior to study entry. NOTE: ART treatment gaps are allowed, but treatment gaps should not exceed 14 consecutive days in the 6 calendar months prior to study entry.
Key exclusion criteria (6 listed)
- Weight ≤30 kg.
- For participants already on ART in Groups 1, 2, and 3, known to have had an ART interruption encompassing the entire 14 day window (≥14 consecutive days) immediately prior to study entry.
- For Group 3, if a participant is already taking TLD at the time of study entry, HIV-1 RNA >1000 copies/mL within the past 9 months while taking TLD with no subsequent HIV-1 RNA ≤1000 copies/mL.
- Prior enrollment in any group in this study.
- For Group 3 participants, already on concomitant TLD and RIF-containing TB treatment prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants achieving virologic success at 6 months (Groups 1, 2, and 4)
Time frame: 6 months +/- 3 months after starting TLD
Proportion of participants on TLD at 6 months achieving virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL. This will be based on the measurement closest to exactly 6 months (i.e., 183 days) after the date of start of TLD, within the window of 6 months ±3 months (specifically 92 to 274 days, inclusive).
Proportion of participants achieving virologic success at end of TLD and RIF-Containing TB Treatment (Group 3)
Time frame: 4 weeks before to 6 months after end of TLD and RIF-containing TB treatment (expect to end concomitant treatment within 12 months of study entry)
Proportion of participants achieving virologic success, defined as suppression of plasma HIV-1 RNA to ≤1000 copies/mL at the end of concomitant TLD and RIF-containing TB treatment. This will be the measurement closest to the end of concomitant treatment within the window of 4 weeks (28 days) before the end to 6 months (183 days) after the end, inclusive.
8 secondary outcomes
Proportion of participants achieving virologic success
Time frame: 6 months, 12 months, 24 months, and 36 months after starting TLD
Proportion of participants with low HIV-1 RNA
Time frame: 12months, 24 months, and 36 months.
Time to confirmed virologic failure (VF)
Time frame: At or after 6 months which is confirmed by the next HIV-1 RNA measurement
Time to confirmed virologic failure with a new DTG resistance-associated mutation
Time frame: From 0 to 36 months
Time from start of TLD to TLD discontinuation
Time frame: From 0 to 36 months
Time from start of TLD to TLD discontinuation due to toxicity.
Time frame: From 0 to 36 months
Change in quality of life (QoL)
Time frame: From study start to 6 months
Time from start of TLD to first occurrence of a targeted clinical event
Time frame: From 0 to 36 months
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 21 Aug 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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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.
Cissy Kityo, MBChB; M.Sc.; Ph.D. study chair
Joint Clinical Research Centre (JCRC)/Kampala CRS
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 14 sites in 6 countries.
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 19 inclusion and 6 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Africa, Kenya, Haiti, Malawi, Uganda and 1 more country. 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?
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?
Proportion of participants achieving virologic success at 6 months (Groups 1, 2, and 4) (time frame: 6 months +/- 3 months after starting TLD). The study lists 2 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 21 Aug 2023.