HIV - Human Immunodeficiency VirusPhase 3COATLNCT07075146
DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
A Phase 3 study testing DOR/3TC/TDF and BIC/FTC/TAF in people with HIV - Human Immunodeficiency Virus and Obesity, run by José Antonio Mata Marín at 1 site in Mexico.
Trial summary
Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV - Human Immunodeficiency Virus, Obesity, Overweight and/or Obesity
- What is being tested?
- DOR/3TC/TDF and BIC/FTC/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteMexico
- Study dates
- 5 May 2025to 1 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve
- Signed informed consent
- HIV-1 RNA ≥1000 copies/mL
- No history of PrEP or PEP failure
- BMI ≥25 kg/m² and body fat >20%
- Stable treatment for dyslipidemia (if applicable)
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- No planned medication changes affecting weight
- Willingness to adhere to assigned ART
- Recent HIV-1 RNA and CD4+ results
- GFR (CKD-EPItip) ≥60 mL/min
- ALT and AST <90 IU/L
- Willingness to report dietary or physical activity changes during follow-up Non-Inclusion Criteria
- 1. Uncontrolled diabetes 2. Recent changes in insulin or hypoglycemic drugs (<3 months) 3. Active malignancy 4. History of bariatric surgery 5. Allergies to study drugs 6. Hepatitis B and/or C coinfection 7. GFR <60 mL/min (CKD-EPI) 8. Drug interactions with ART regimens 9. Recent (60 days) use of anorectic drugs 10. Recent (30 days) hospitalization for severe illness 11. Unstable hypothyroidism
Who cannot join
- Loss of social security coverage
- Newly discovered allergy to study drugs
- Withdrawal of consent
- Hepatitis B or C infection acquired during follow-up
- Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks
- Initiation or discontinuation of medications affecting weight after enrollment
- Unplanned bariatric surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, 02990
José A Mata, Master degree, 525530379053, jamatamarin@gmail.com
Ana C Díaz, postgraduate, ana.knodiaz@gmail.com
About this study
Official title: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate COmpared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity
Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a "return to health" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg/m² and body fat >20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR/3TC/TDF or BIC/FTC/TAF.
Read the detailed description
Study Assessments Measurements: Laboratory tests, vital signs, and body composition (via bioimpedance) will be assessed at weeks 4, 12, 24, 36, 48, 72, 96, 120, and 144. HIV viral load and CD4+ count will be measured at weeks 12, 24, 48, 72, 96, 120, and 144.Statistical Methods: Non-probabilistic sampling will be used. Data distribution will be evaluated with the Kolmogorov-Smirnov test. Descriptive statistics (means, medians, percentages) will be reported. Between-group comparisons will use the Mann-Whitney U test for continuous variables and chi-square or Fisher's exact test for categorical variables. Longitudinal analysis at weeks 12, 24, 48, 96, and 144 will employ the Wilcoxon test. A p-value ≤0.05 with a 95% confidence interval will indicate statistical significance.Study ProcedureEligible ART-naïve PWH attending the HIV clinic will be identified and invited to participate. After providing informed consent, participants will be informed that participation is voluntary and can be withdrawn at any time without consequences.
Baseline Visit
- Data Collection: A medical interview will gather sociodemographic, clinical, and comorbidity data, as well as lifestyle habits (diet, physical activity, alcohol use, smoking).
- Anthropometric Measurements: Conducted using a 4-point segmental bioimpedance scale (FitScan Segmental Body Composition Monitor C-545F) to assess weight, water percentage, muscle mass, bone mass, and fat percentage. Waist and hip circumference, blood pressure, heart rate, respiratory rate, and oxygen saturation will also be measured.
- Laboratory Assessments: Include glucose, creatinine, cystatin C, serum and urinary electrolytes, lipid profile, liver function tests, elastography (visceral and subcutaneous fat), complete blood count, HIV viral load, CD4+ count, hepatitis B and C serologies, and VDRL.
Randomization and Follow-Up Participants will be randomized using the MEDSHARING digital system to either DOR/3TC/TDF or BIC/FTC/TAF. Follow-up visits will occur at specified intervals through week 144. Adverse events will be monitored using the DAIDS grading scale. Neuropsychiatric assessments will use the Hospital Anxiety and Depression Scale (HADS), Insomnia Severity Index (ISI), and Patient Health Questionnaire (PHQ-9). Treatment satisfaction and distress will be evaluated with the HIV Treatment Satisfaction Questionnaire (HIVTSQ) and HIV Symptom Distress Module (HIVSDM).
Sampling and Sample Size
Simple random sampling will be employed. The sample size is 306 participants per group, calculated based on:
- 80% statistical power
- Alpha level of 0.05
- 12% non-inferiority margin
- 80% expected virologic response at week 48
- 10% attrition rate Statistical Analysis
- Categorical Variables: Reported as frequencies and percentages.
- Continuous Variables: Described using means ± standard deviations or medians with interquartile ranges.
- Statistical Tests:
- Between-group comparisons: Mann-Whitney U or Student's t-test
- Within-group comparisons: Wilcoxon or paired t-test
- Multiple time points: Friedman or repeated-measures ANOVA
- Associations: Chi-square or Fisher's exact test
- Multivariate analysis: Binary logistic regression
- Software: SPSS v29.0.2 for Mac (IBM) will be used for data analysis. Ethical Considerations and Data Confidentiality The study adheres to the Declaration of Helsinki, CIOMS/WHO, and ICH-GCP guidelines. Approval has been obtained from the institutional Ethics and Research Committee. Participant confidentiality will comply with IMSS policy and Mexican regulations, using anonymized unique codes. Only standard-of-care treatments per national and international guidelines will be used. Risks are minimal, primarily related to venipuncture, with medical evaluation and treatment provided as needed
- Being tested
- DOR/3TC/TDF, BIC/FTC/TAF
- Keywords
- HIV, overweight, obesity, Doravirine, Bictegravir
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOR/3TC/TDFDrug
It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100/300/300 mg
BIC/FTC/TAFDrug
It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains bictegravir 50 mg, tenofovir alafenamide 25 mg, and emtricitabine 200 mg. It is the standard therapy.
| Study group | Role | What they receive |
|---|---|---|
| BIC/TAF/FTC | Active comparator | Bictegravir/ tenofovir alafenamide/ emtricitabine 50/ 25/ 200 mg. It is the usual therapy, consisting of 3 drugs in a single tablet, based on an integrase inhibitor, and 2 nucleoside analogues, it is the experimental group Receives: Drug: BIC/FTC/TAF |
| DOR/3TC/TDF | Experimental | Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100/300/300 mg Non-nucleoside reverse transcriptase inhibitor (doravirine) Nucleoside reverse transcriptase inhibitors (lamivudine, tenofovir disoproxil fumarate) Receives: Drug: DOR/3TC/TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of Doravirine/Lamivudine/Tenofovir compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment.
Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DOR/TDF/3TC or BIC/FTC/TAF at 144 weeks, expressed in proportions of new cases.
Measured: 144 weeks
Evaluate the effectiveness and safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Effectiveness: Number of participants with viral load measurement (HIV-1 RNA) <50 copies/mL at 144 weeks of follow-up for PWH treated with DOR/3TC/TDF or BIC/FTC/TAF,BIC/FTC/TAF at 144 weeks,
Measured: 144 weeks of follow-up with interim analysis at 48 and 96 weeks
Secondary outcomes (4)
To compare changes in lipid profile in people living with HIV (PLWH) treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide after initiating ART
Measured: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
To compare changes in body composition in PLWH treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide before initiating ART
Changes of percentage of fat
Measured: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
To compare changes in estimated glomerular filtration rate (eGFR) in PLWH treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide after initiating TAR
To compare changes in kidney function using cystatin C and creatinine levels calculated using the 2021 CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation: Creatinine-Cystatin C expressed in ml/min/1.73 m2.
Classifying kidney function stages:
Stage 1: Normal (GFR >90 ml/min/m2) Stage 2: Mild (GFR 60-89 ml/min/m2) Stage 3: Moderate (GFR 30-59 ml/min/m2) Stage 4: Severe (GFR 15-29 ml/min/m2) Stage 5: Renal failure for dialysis (GFR <15 ml/min/m2)
Measured: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
To compare changes in cardiovascular risk using the Framingham Risk Score and the Pooled Cohort Equations (ASCVD AHA/ACC) in PLWH treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide
To evaluate and compare changes in cardiovascular risk based on the ASCVD (Atherosclerotic Cardiovascular Disease) 2013 Risk Calculator from American College of Cardiology (ACC) and American Heart Association in ART-naive PWH initiating DOR/3TC/TDF regimen compared with BIC/FTC/TAF after 144 weeks of follow-up.
To evaluate in percentages of risk High cardiovascular risk: ≥20% Borderline cardiovascular risk: ≥5%-<7.5% Low cardiovascular risk: <5% The score is directly proportional to the risk, and determines the 10-year risk of ASCVD, (Atherosclerotic Cardiovascular Disease) for example: myocardial infarction, stroke, or death due to coronary heart disease or stroke
Measured: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start5 May 2025
- Primary completion5 Jun 2026 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV - Human Immunodeficiency VirusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design: Experimental, longitudinal, prospective, randomized 1:1, open-label. Study type: Open-label, randomized clinical trial. Study location: Infectious Diseases Hospital. Study duration: 144 weeks
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- José Antonio Mata Marín
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor-investigator, José Antonio Mata Marín, Instituto Mexicano del Seguro Social
- Investigators
- José A Mata, M.Sc, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075146
- Sponsor's protocol ID
- R-2025-3502-101
- Acronym
- COATL
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data are confidential and may be requested from the principal investigator.
Publications
Kousari AE, Wilson MP, Hawkins KL, Bandali MM, Henao-Martinez AF, Gardner EM, Erlandson KM. Weight change with antiretroviral switch from integrase inhibitor or tenofovir alafenamide-based to Doravirine-Based regimens in people with HIV. HIV Res Clin Pract. 2024 Dec;25(1):2339576. Epub 2024 Jun 3.
PubMed 38831550Orkin C, Molina JM, Cahn P, Lombaard J, Supparatpinyo K, Kumar S, Campbell H, Wan H, Teal V, Jin Xu Z, Asante-Appiah E, Sklar P, Teppler H, Lahoulou R; DRIVE-FORWARD and DRIVE-AHEAD collaborators. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials. Lancet HIV. 2024 Feb;11(2):e75-e85. doi: 10.1016/S2352-3018(23)00258-8. Epub 2023 Dec 20.
PubMed 38141637
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate COmpared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07075146
- Acronym / sponsor ID
- COATL / R-2025-3502-101
- Keywords
- HIV, overweight, obesity, Doravirine, Bictegravir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- José Antonio Mata MarínOther government
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 20 Jul 2025 (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.
Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a "return to health" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg/m² and body fat >20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR/3TC/TDF or BIC/FTC/TAF.
Detailed description
Study Assessments Measurements: Laboratory tests, vital signs, and body composition (via bioimpedance) will be assessed at weeks 4, 12, 24, 36, 48, 72, 96, 120, and 144. HIV viral load and CD4+ count will be measured at weeks 12, 24, 48, 72, 96, 120, and 144.Statistical Methods: Non-probabilistic sampling will be used. Data distribution will be evaluated with the Kolmogorov-Smirnov test. Descriptive statistics (means, medians, percentages) will be reported. Between-group comparisons will use the Mann-Whitney U test for continuous variables and chi-square or Fisher's exact test for categorical variables. Longitudinal analysis at weeks 12, 24, 48, 96, and 144 will employ the Wilcoxon test. A p-value ≤0.05 with a 95% confidence interval will indicate statistical significance.Study ProcedureEligible ART-naïve PWH attending the HIV clinic will be identified and invited to participate. After providing informed consent, participants will be informed that participation is voluntary and can be withdrawn at any time without consequences.
Baseline Visit
- Data Collection: A medical interview will gather sociodemographic, clinical, and comorbidity data, as well as lifestyle habits (diet, physical activity, alcohol use, smoking).
- Anthropometric Measurements: Conducted using a 4-point segmental bioimpedance scale (FitScan Segmental Body Composition Monitor C-545F) to assess weight, water percentage, muscle mass, bone mass, and fat percentage. Waist and hip circumference, blood pressure, heart rate, respiratory rate, and oxygen saturation will also be measured.
- Laboratory Assessments: Include glucose, creatinine, cystatin C, serum and urinary electrolytes, lipid profile, liver function tests, elastography (visceral and subcutaneous fat), complete blood count, HIV viral load, CD4+ count, hepatitis B and C serologies, and VDRL.
Randomization and Follow-Up Participants will be randomized using the MEDSHARING digital system to either DOR/3TC/TDF or BIC/FTC/TAF. Follow-up visits will occur at specified intervals through week 144. Adverse events will be monitored using the DAIDS grading scale. Neuropsychiatric assessments will use the Hospital Anxiety and Depression Scale (HADS), Insomnia Severity Index (ISI), and Patient Health Questionnaire (PHQ-9). Treatment satisfaction and distress will be evaluated with the HIV Treatment Satisfaction Questionnaire (HIVTSQ) and HIV Symptom Distress Module (HIVSDM).
Sampling and Sample Size
Simple random sampling will be employed. The sample size is 306 participants per group, calculated based on:
- 80% statistical power
- Alpha level of 0.05
- 12% non-inferiority margin
- 80% expected virologic response at week 48
- 10% attrition rate Statistical Analysis
- Categorical Variables: Reported as frequencies and percentages.
- Continuous Variables: Described using means ± standard deviations or medians with interquartile ranges.
- Statistical Tests:
- Between-group comparisons: Mann-Whitney U or Student's t-test
- Within-group comparisons: Wilcoxon or paired t-test
- Multiple time points: Friedman or repeated-measures ANOVA
- Associations: Chi-square or Fisher's exact test
- Multivariate analysis: Binary logistic regression
- Software: SPSS v29.0.2 for Mac (IBM) will be used for data analysis. Ethical Considerations and Data Confidentiality The study adheres to the Declaration of Helsinki, CIOMS/WHO, and ICH-GCP guidelines. Approval has been obtained from the institutional Ethics and Research Committee. Participant confidentiality will comply with IMSS policy and Mexican regulations, using anonymized unique codes. Only standard-of-care treatments per national and international guidelines will be used. Risks are minimal, primarily related to venipuncture, with medical evaluation and treatment provided as needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design: Experimental, longitudinal, prospective, randomized 1:1, open-label. Study type: Open-label, randomized clinical trial. Study location: Infectious Diseases Hospital. Study duration: 144 weeks
| Arm | Type | Receives |
|---|---|---|
| BIC/TAF/FTC | Active comparator | Drug: BIC/FTC/TAFBictegravir/ tenofovir alafenamide/ emtricitabine 50/ 25/ 200 mg. It is the usual therapy, consisting of 3 drugs in a single tablet, based on an integrase inhibitor, and 2 nucleoside analogues, it is the experimental group |
| DOR/3TC/TDF | Experimental | Drug: DOR/3TC/TDFDoravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100/300/300 mg Non-nucleoside reverse transcriptase inhibitor (doravirine) Nucleoside reverse transcriptase inhibitors (lamivudine, tenofovir disoproxil fumarate) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve
- Signed informed consent
- HIV-1 RNA ≥1000 copies/mL
- No history of PrEP or PEP failure
- BMI ≥25 kg/m² and body fat >20%
Key exclusion criteria (7 listed)
- Loss of social security coverage
- Newly discovered allergy to study drugs
- Withdrawal of consent
- Hepatitis B or C infection acquired during follow-up
- Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks
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 |
|---|---|---|
| DOR/3TC/TDFIt is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100/300/300 mg | Drug | DOR/3TC/TDF |
| BIC/FTC/TAFIt is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains bictegravir 50 mg, tenofovir alafenamide 25 mg, and emtricitabine 200 mg. It is the standard therapy. | Drug | BIC/TAF/FTC |
Primary outcome
To determine the safety and tolerability of Doravirine/Lamivudine/Tenofovir compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment.
Time frame: 144 weeks
Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DOR/TDF/3TC or BIC/FTC/TAF at 144 weeks, expressed in proportions of new cases.
Evaluate the effectiveness and safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Time frame: 144 weeks of follow-up with interim analysis at 48 and 96 weeks
Effectiveness: Number of participants with viral load measurement (HIV-1 RNA) <50 copies/mL at 144 weeks of follow-up for PWH treated with DOR/3TC/TDF or BIC/FTC/TAF,BIC/FTC/TAF at 144 weeks,
4 secondary outcomes
To compare changes in lipid profile in people living with HIV (PLWH) treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide after initiating ART
Time frame: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
To compare changes in body composition in PLWH treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide before initiating ART
Time frame: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
To compare changes in estimated glomerular filtration rate (eGFR) in PLWH treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide after initiating TAR
Time frame: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
To compare changes in cardiovascular risk using the Framingham Risk Score and the Pooled Cohort Equations (ASCVD AHA/ACC) in PLWH treated with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate versus Bictegravir/Emtricitabine/Tenofovir Alafenamide
Time frame: 144 weeks, with interim analyses at 24,48,72, 96 , 120, and 144 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 38831550Kousari AE, Wilson MP, Hawkins KL, Bandali MM, Henao-Martinez AF, Gardner EM, Erlandson KM. Weight change with antiretroviral switch from integrase inhibitor or tenofovir alafenamide-based to Doravirine-Based regimens in people with HIV. HIV Res Clin Pract. 2024 Dec;25(1):2339576. Epub 2024 Jun 3.
- Background: PubMed 38141637Orkin C, Molina JM, Cahn P, Lombaard J, Supparatpinyo K, Kumar S, Campbell H, Wan H, Teal V, Jin Xu Z, Asante-Appiah E, Sklar P, Teppler H, Lahoulou R; DRIVE-FORWARD and DRIVE-AHEAD collaborators. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials. Lancet HIV. 2024 Feb;11(2):e75-e85. doi: 10.1016/S2352-3018(23)00258-8. Epub 2023 Dec 20.
- Individual participant dataSharing planned: No. Participant data are confidential and may be requested from the principal investigator.
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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.
José A Mata, M.Sc principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DOR/3TC/TDF and BIC/FTC/TAF in people with HIV - Human Immunodeficiency Virus and Obesity, run by José Antonio Mata Marín at 1 site in Mexico.
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 13 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José A Mata, M.Sc (525530379053, jamatamarin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and tolerability of Doravirine/Lamivudine/Tenofovir compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment. (time frame: 144 weeks). 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?
On the ClinicalTrials.gov record for NCT07075146, which also lists 2 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 24 Aug 2025.