A Phase 4 interventional study of Integrase inhibitor and Doravirine + tenofovir DF + lamivudine in HIV, HIV Associate Weight Loss and HIV-1 Infection, sponsored by Instituto Mexicano del Seguro Social. Recruiting at 2 sites in Mexico. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Instituto Mexicano del Seguro Social · Phase 4, Interventional, and Treatment
Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine/lamivudine/disoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.
Open-label, randomized clinical trial, conducted at the infectious disease hospital, La Raza National Medical Center, Mexico City, from July 2024 to November 2025.
The aim of the study is to determine the percentage change in body weight and BMI in virologically suppressed PWH maintaining a second-generation INSTI (BIC/TAF/FTC, DTG/ABC/3TC or DTG+TDF/FTC) regimen compared with those switching to DOR/3TC/TDF at 48 weeks post-switch.
PWH who are on a second-generation INSTI regimen who are virologically suppressed (HIV-1 RNA minor to 50 copies/mL) and have gained ≥10% of their body weight compared to their weight before starting ART, BMI ≥25 kg/m2, and body fat greater than 20% will be identified, and invited to participate.
A medical interview will be conducted to assess clinical characteristics, comorbidities of the study subject, new drugs, changes in doses or suspensions, as well as plans by their other physicians for changes in the same, diet, frequency and intensity of exercise. Once the preliminary information has been obtained, it will be established whether the patient is a candidate to take part in the study and will be invited to participate voluntarily. The project and the probable results, benefits and risks of participating will be explained in detail and in detail; If they agree to participate, informed consent will be obtained from the principal investigator or associate researchers during the medical visit where weight gain and BMI are identified, for authorization to take clinical exams, anthropometric measurements (these will be carried out by the principal investigator or associates). A response will be obtained during the same medical visit with free decision to continue or withdraw from the study at the time deemed appropriate during the study period without this affecting your medical care at the HIV clinic. (Annex 1) Patients who accept will be asked again for HIV-1 RNA, CD4+, complete blood count, lipid profile, complete liver enzymes, cystatin C and urinary electrolytes within 45 days prior to randomization, and if they meet the inclusion criteria, through simple randomization and with the randomizer for clinical trial application, the principal investigator will randomize them into the group of maintaining the previous regimen with second-generation INSTI or changing the regimen to DOR/3TC/TDF, and in order to maintain privacy, a folio number will be assigned at the time of recruitment.
Weight measurements will be taken with a FitScan segmental body composition monitor BC-545F scale, height in centimeters, body mass index (BMI) with the formula weight (kg)/height (m2), body composition (fat in %, water in %, muscle in kg, bone in kg) with a FitScan segmental body composition monitor BC-545F equipment, waist and hip measurements with a measuring tape in cm.
Laboratory studies will include complete blood count, complete blood chemistry with glucose, creatinine, complete lipid profile, and liver function tests after randomization at 4 weeks, 12 weeks, 24 weeks, and 48 weeks post-switch. CD4+, HIV-1 RNA, Cystatin C, and urinary electrolytes will be determined prior to randomization, at 6 months, and 12 months after entering the study. Comparisons will be made between measurements taken prior to entering the study, at 24 and 48 weeks after entering the study.
In case of elevated AST and/or ALT \>90 IU/L, serologies will be requested to rule out HBV and HCV.
The PSQI, ISI, HADS-A, and HADS-D questionnaires will be used to assess anxiety, depression, and sleep quality; in addition, the HIVTSQ questionnaire will be used to assess treatment satisfaction at weeks 4, 12, 24, and 48 weeks after randomization, and HIV Symptoms Distress Module (HIV-SDM).
The change in weight and BMI at 48 weeks will be defined as the difference between the weight and BMI prior to randomization compared to the results at 48 weeks, weight will be expressed in kg, percentages and BMI in kg/m2.
The sampling was simple random, participation in the study was offered to all Mexican patients living with HIV who have gained ≥10% of body weight and BMI ≥25% from a regimen with second-generation integrase inhibitor (BIC/TAF/FTC or DTG/ABC/3TC).
Sample size per group: 54 participants per group. Calculated based on the expected change after switching from INSTI to a regimen with DOR/TDF/3TC, with estimated losses of 20%, 108 participants in total.
Kolmogorov-Smirnoff test will be used to identify distribution of data and to express central tendency measures (medians with interquartile ranges) and percentages accordingly. Data will be compared using the Mann-Whitney U test. Qualitative data will be analyzed using the x2 or Fisher´s exact test, as appropriate. Subsequently, data will be analyzed by groups at 12, 24, 36, and 48 weeks using the Wilcoxon test. A P value ≤0.05 with a 95% confidence interval will be considered statistically significant.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
This study's planned enrollment of 108 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →Instituto Mexicano del Seguro Social is the lead sponsor of 126 studies on the registry; 21 are open to participants now.
Compared within Weight Loss, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Weight Changes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Second generation integrase inhibitor: 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC) 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine 300 mg (DTG/ABC/3TC) or ) dolutegravir 50 mg+ disoproxil fumarate tenofovir/ emtricitabine 300mg/ 200 mg (DTG+TDF/FTC) Each will be prescribed one tablet every day during 48 weeks
Drug: Integrase inhibitor
Individuals who meet the selection criteria will be randomized to maintain their same regimen with second-generation integrase inhibitors or switch to Doravirine/Tenofovir Disoproxil Fumarate/Emtricitabine 100/300/300 mg (DOR/TDF/3TC) It will be prescribed one tablet every day during 48 weeks
Drug: Doravirine + tenofovir DF + lamivudine
Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine 300 mg (DTG/ABC/3TC); 3) DTG 50mg+TDF 300mg/FTC 200mg (DTG+TDF/FTC) Each will be prescribed one tablet every day during 48 weeks
Drug pages: Doravirine · Tenofovir · Lamivudine
Individuals who meet the selection criteria will be randomized to maintain their same regimen with second-generation integrase inhibitors or switch to DOR/TDF/3TC 100/ 300/300 mg It will be prescribed one tablet every day during 48 weeks
Change in body weight and BMI
To determine the percentage change in body weight and BMI in virologically suppressed PLHIV maintaining a second-generation INSTI regimen compared with those switching to DOR/3TC/TDF at 48 weeks post-switch. This will be measured with with the same scale at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Time frame: 48 weeks
Adverse events
Evaluate the number and degree of adverse events in each group of ART at baseline, 1 month, 3 months, 6 months, 9 months and 12 months post-recruitment
Time frame: 48 weeks
Evaluate neuropsychiatric disorders
Assess sleep quality using the Insomnia Severity Score (ISI) baseline and at 48 weeks Assess anxiety and depression using the Hospital Anxiety and Depression Scales (HADS-A and HADS-D) baseline and at 48 weeks Assess the presence and degree of depression using the Patient Health Questionnaire-9 (PHQ-9) baseline and at 48 weeks. This will be measured at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Time frame: 48 weeks
Changes in lipid profile
Analyze changes in total cholesterol, hdl cholesterol and triglycerides at baseline and 48 weeks after switch. This will be evaluated at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Time frame: 48 weeks
Analyze changes in body composition
Fat in percentage, muscle in kilograms, water in percentage and bone in kilograms. This will be evaluated with same bioimpedance equipment at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Time frame: 48 weeks
Cardiovascular risk
Determine cardiovascular risk using Framingham scale and Atherosclerotic Cardiovascular Disease. (ASCVD) at baseline an 48 weeks. This will be evaluated at baseline, 6 months, and 12 months.
Time frame: 48 weeks
Kidney function
Analyze changes in renal function using creatinine, cystatin C, and urinary electrolytes at baselina and 48 weeks. This will be evaluated at baseline, 6 months, and 12 months.
Time frame: 48 weeks
HIVSDM scale symptom distress scale
Symptom distress an instrument to identify perceived individual symptoms reported by HIV infected patients. The construct distress, in an HIV population, is characterized by phenomena such as fatigue/low energy, fevers, dizziness, tingling/hand/foot pain, memory loss, nausea/vomiting, diarrhea, depression, anxiety, sleep problems, skin problems, cough/shortness of breath, headache, appetite loss, bloating/gas, muscle/joint pain, sexual problems, weight gain weight loss, and hair loss. This will be measured at baseline, 1 month, 3 months, 6 months, 9 months and 12 months.
Time frame: 48 weeks
HIV Treatment Satisfaction Questionnaire (HIVTSQ)
The HIV treatment Satisfaction Questionnaire is a Patient-reported questionnaire that assesses treatment satisfaction, specific to patients with HIV-1. Is a10-item self-answered where they are asked to respond to each of 10 questions, by circling a number (0-6), this will be measured at baseline, 1 month, 3, 6, 9 and 12 months after switch.
Time frame: 48 weeks
Plan to share: No — Individual participant data will be shared if necessary, as it contains personal and sensitive information about participants.
Started Aug 2024 (actual). Primary completion is estimated for Nov 2025, 15 months after the start.
Of 40 non-industry phase 4 interventional studies under Weight Loss, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 51. This study's planned 15 months is below that.
Counting every sponsor, half of 45 studies reached it within 29 months; a quarter within 19 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Doravirine · Tenofovir · Lamivudine
Instituto Mexicano del Seguro Social →