A Phase 4 interventional study of dual therapy and Standard Medical Therapy in HIV Infection, sponsored by José Antonio Mata Marín. Recruiting at 1 site in Mexico. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by José Antonio Mata Marín · Phase 4, Interventional, and Treatment
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.
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:
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 138 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →José Antonio Mata Marín is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Darunavir/cobicistat 800/150 mg + tenofovir/emtricitabin 300/200 mg This arm is the commonly used therapy or standard 3-drug therapy consisting of Darunavir/cobicistad 800/150 mg, plus tenofovir/emtricitabine 300/200 mg
Drug: Standard Medical Therapy
Darunavir/cobicistat 800/150 mg + lamivudine 300 mg This arm is the experimental one, with dual therapy, 2 drugs: darunavir/cobicistat 800/150 mg plus lamivudine 300 mg
Drug: dual therapy
Intervention arm will be dual therapy oh DRV/C 800/150 mg + 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: DRV/c 800/150 mg + TDF/FTC 300/200 mg
Also known as: DRV/c+3TC
DRV/c+TDF/FTC
Also known as: DRV/c+TDF/FTC
Effectiveness
Individuals with \>50 copies/ml
Time frame: 48 weeks
Non-inferiority
Delta between standard and experimental therapy \<10%
Time frame: 48 weeks
Safety
Adverse events by group and drug tolerability will be reported by device and system, and their severity will be based on the Division of AIDS (DAIDS) Antiretroviral Drug-Associated Adverse Event Severity Scale, which categorizes them in severity from 1 to 4. Grade 1: Mild or no harm; Grade 2: Moderate adverse events or minimal interference with social and functional activities; Grade 3: Severe symptoms causing inability to perform social/functional activities or requiring hospitalization. Grade IV: Those that are life-threatening with symptoms causing inability to perform basic self-care and where intervention is required to prevent permanent deterioration or death.
Time frame: 48 weeks
Plan to share: No — The data cannot be shared openly because it contains personal information about the participants; if required, it can be requested from the corresponding author.
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José Antonio Mata Marín