Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06907056
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico
Sponsor:
José Antonio Mata Marín
Organization:
Study Overview
Official Title:
Effectiveness, Safety, and Tolerability of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals: 48-week Follow-up in Mexico
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TLALOC
Brief Summary:
Unicenter, open-label, randomized, noninferiority trial included men with HIV-1 RNA levels \<50 copies/ml for at least 6 months on antiretroviral therapy with DRV/c + TFV/FTC (standar therapy), aged over 18 years. Participants were randomized to either continue standard therapy or switch to DRV/c+3TC. The primary end point was the proportion of subjects with HIV-1 RNA levels \>50 copies/ml after 48 weeks of follow-up according to the snapshot algorithm, with a non-inferiority margin of up to 10%. For statistical analysis, data distribution will be identified using the Kolmogorov-Smirnov test; categorical data will be analyzed using the X2 or Fisher test, as appropriate, and will be expressed as numbers and percentages. Quantitative data will be expressed as medians and interquartile ranges or means with standard deviations. A first analysis will be performed at 24 weeks, with follow-up at 48 weeks. The Student's t-test or the Mann-Whitney U-test will be used for data from independent groups according to their distribution.
Detailed Description:
Unicenter, open-label, randomized, noninferiority trial included men with HIV-1 RNA levels \<50 copies/ml for at least 6 months on antiretroviral therapy with DRV/c + TFV/FTC (standar therapy), aged over 18 years. Participants were randomized to either continue standard therapy or switch to DRV/c+3TC. The primary end point was the proportion of subjects with HIV-1 RNA levels \>50 copies/ml after 48 weeks of follow-up according to the snapshot algorithm, with a non-inferiority margin of up to 10%. For statistical analysis, data distribution will be identified using the Kolmogorov-Smirnov test; categorical data will be analyzed using the X2 or Fisher test, as appropriate, and will be expressed as numbers and percentages. Quantitative data will be expressed as medians and interquartile ranges or means with standard deviations. A first analysis will be performed at 24 weeks, with follow-up at 48 weeks. The Student's t-test or the Mann-Whitney U-test will be used for data from independent groups according to their distribution.
Subject to prior approval of the protocol by the local scientific research ethics committee and the relevant agencies, patients being monitored at the HIV clinic at the Infectious Diseases Hospital of the CMN "La Raza" who are living with HIV and receiving treatment with DRV/c + TFV/FTC for virological suppression will be identified as candidates for participation in the study.
They will be invited to participate in the study protocol, and the project and its likely outcomes will be explained in detail to the subjects. It will be explained that treatment assignment will be randomized using the digital system (MEDSHARING: randomizer for clinical trials) to one of two arms:
1. DRV/c (800 mg/150 mg once daily) + 3TC (300 mg once daily) or
2. DRV/c (800 mg/150 mg once daily) + TFV/FTC (300 mg/200 mg once daily). Answers will be obtained during the medical interview, allowing the patient to freely decide whether to continue or withdraw from the study during the study period without affecting their medical care at the HIV clinic. Informed consent will be obtained, and to maintain privacy, a patient ID number will be assigned at the time of recruitment. Weight (kg), height (cm), body mass index (BMI) (kg/height (m2), body composition (fat, water, muscle, kg, bone, kg) will be measured using the FitScan BC-545F segmental body composition monitor, and waist and hip measurements will be measured using a tape measure. Laboratory studies will include a complete blood count, complete blood chemistry with glucose and creatinine, a complete lipid profile, and post-randomization liver function tests at 4 weeks, 12 weeks, 24 weeks, and 48 weeks post-switch. CD4+ and HIV-1 RNA determinations will be performed prior to randomization, and at 3 months, 6 months, and 12 months post-study entry. Comparisons will be made between measurements taken prior to entry, 24 weeks, and 48 weeks post-study entry. Serum electrolytes (phosphorus, magnesium, calcium), cystatin C, and urinary electrolytes (phosphorus, magnesium, calcium, creatinine, urea, microproteins) will be measured prior to randomization and at 24 and 48 weeks post-switch.
If patients present with elevated AST and/or ALT \>90 IU/L, serology tests will be ordered to rule out HBV and HCV.
The ISI, PHQ-9, HADS-A, and HADS-D questionnaires will be administered to assess anxiety, depression, and sleep quality. Additionally, the HIVTSQ questionnaire will be administered to assess treatment satisfaction at weeks 4, 12, 24, and 48 weeks post-randomization, and the HIV-SDM questionnaire will be administered to assess HIV-related symptoms and distress. At each medical visit, potential drug-related adverse effects will be deliberately inquired about by device and system, and will be classified into four grades using the DAIDS adverse event scale.
Subject to prior approval of the protocol by the local scientific research ethics committee and the relevant agencies, patients being monitored at the HIV clinic at the Infectious Diseases Hospital of the CMN "La Raza" who are living with HIV and receiving treatment with DRV/c + TFV/FTC for virological suppression will be identified as candidates for participation in the study.
They will be invited to participate in the study protocol, and the project and its likely outcomes will be explained in detail to the subjects. It will be explained that treatment assignment will be randomized using the digital system (MEDSHARING: randomizer for clinical trials) to one of two arms:
1. DRV/c (800 mg/150 mg once daily) + 3TC (300 mg once daily) or
2. DRV/c (800 mg/150 mg once daily) + TFV/FTC (300 mg/200 mg once daily). Answers will be obtained during the medical interview, allowing the patient to freely decide whether to continue or withdraw from the study during the study period without affecting their medical care at the HIV clinic. Informed consent will be obtained, and to maintain privacy, a patient ID number will be assigned at the time of recruitment. Weight (kg), height (cm), body mass index (BMI) (kg/height (m2), body composition (fat, water, muscle, kg, bone, kg) will be measured using the FitScan BC-545F segmental body composition monitor, and waist and hip measurements will be measured using a tape measure. Laboratory studies will include a complete blood count, complete blood chemistry with glucose and creatinine, a complete lipid profile, and post-randomization liver function tests at 4 weeks, 12 weeks, 24 weeks, and 48 weeks post-switch. CD4+ and HIV-1 RNA determinations will be performed prior to randomization, and at 3 months, 6 months, and 12 months post-study entry. Comparisons will be made between measurements taken prior to entry, 24 weeks, and 48 weeks post-study entry. Serum electrolytes (phosphorus, magnesium, calcium), cystatin C, and urinary electrolytes (phosphorus, magnesium, calcium, creatinine, urea, microproteins) will be measured prior to randomization and at 24 and 48 weeks post-switch.
If patients present with elevated AST and/or ALT \>90 IU/L, serology tests will be ordered to rule out HBV and HCV.
The ISI, PHQ-9, HADS-A, and HADS-D questionnaires will be administered to assess anxiety, depression, and sleep quality. Additionally, the HIVTSQ questionnaire will be administered to assess treatment satisfaction at weeks 4, 12, 24, and 48 weeks post-randomization, and the HIV-SDM questionnaire will be administered to assess HIV-related symptoms and distress. At each medical visit, potential drug-related adverse effects will be deliberately inquired about by device and system, and will be classified into four grades using the DAIDS adverse event scale.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R-2024-3502-116 | OTHER | Instituto Mexicano Del Seguro Social | View |