Comparing two HIV treatment regimens in men with suppressed viral loads
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
This study is testing if a new combination of HIV medications can work just as well as the standard treatment for men who have their virus under control.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT06907056 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of a dual therapy regimen using Darunavir/Cobicistat plus Lamivudine compared to the standard therapy of Darunavir/Cobicistat plus Tenofovir/Emtricitabine in men who are virologically suppressed for at least six months. Participants will be randomly assigned to either continue their current treatment or switch to the new regimen, with follow-up assessments at 24 and 48 weeks to monitor viral load levels. The study aims to determine if the new regimen is non-inferior to the standard treatment in maintaining viral suppression.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 70 years who have been virologically suppressed on standard therapy for at least six months.
Not a fit: Patients with active opportunistic infections or those desiring a single-dose regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more simplified treatment option for HIV-positive patients, potentially improving adherence and quality of life.
How similar studies have performed: Other studies have shown promising results with similar dual therapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men with HIV infection who are virologically suppressed with DRV/c (800 mg/150 mg) + TFV/FTC (300 mg/200 mg) for at least 6 months * Age ≥18 years-70 years * eGFR ≥30 mL/min * Written informed consent * Beneficiaries of the Mexican Social Security Institute treated at the Infectious Diseases Hospital of the La Raza National Medical Center. Exclusion Criteria: * Withdrawal of informed consent * Loss of medical insurance * Presence of tuberculosis or other opportunistic infection requiring adjustment of the ARV regimen * Incomplete data collected during visits Uncontrolled chronic gastrointestinal conditions Desire to be on a single-dose regimen Coinfection with hepatitis B virus during follow-up if in the DRV/3TC arm Coinfection with hepatitis C virus during follow-up
Where this trial is running
Mexico City, Mexico City
- Hospital de Infectología, Centro Médico Nacional La Raza — Mexico City, Mexico City, Mexico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.