A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain
Public ClinicalTrials.gov record NCT04442737. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have experienced rapid and significant body weight gain.
Study identification
- NCT ID
- NCT04442737
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2020 (Actual)
- Primary completion
- Aug 7, 2023 (Actual)
- Completion
- Aug 30, 2023 (Actual)
- Last update posted
- Mar 30, 2025
2020 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35222 | — |
| The Office of Franco Felizarta, MD | Bakersfield | California | 93301 | — |
| AIDS Health Foundation-Westside HCC | Beverly Hills | California | 90211 | — |
| Long Beach Education & Research Consultants | Long Beach | California | 90813 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Triple O Research Institute | West Palm Beach | Florida | 33407 | — |
| Atlanta ID Group | Atlanta | Georgia | 30309 | — |
| Medical College of Georgia | Augusta | Georgia | 30912 | — |
| The Corporation of Mercer University | Macon | Georgia | 31201 | — |
| Chatham County Health Department | Savannah | Georgia | 31401 | — |
| The Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Care South Clinic | Baton Rouge | Louisiana | 70806 | — |
| Kaiser Permanente | Rockville | Maryland | 20852 | — |
| Community Research Initiative | Boston | Massachusetts | 02129 | — |
| Be Well Medical Center, PC | Berkley | Michigan | 48072 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska | Omaha | Nebraska | 68106 | — |
| Saint Michaels Medical Center - Infectious Disease | Newark | New Jersey | 07102 | — |
| AIDS Healthcare Foundation-Research Center | New York | New York | 10001 | — |
| Mount Sinai Hospital-New York | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia Fight | Philadelphia | Pennsylvania | 19107 | — |
| Palmetto Health - USC | Columbia | South Carolina | 29203 | — |
| AIDS Arms Incorporated Trinity Health and Wellness Center | Dallas | Texas | 75208 | — |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | — |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Therapeutic Concepts - Donald R Watkins Foundation | Houston | Texas | 77004 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Infectious Disease Associates of Central Virginia | Lynchburg | Virginia | 24501 | — |
| Vivent Health | Milwaukee | Wisconsin | 53203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04442737, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 30, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04442737 live on ClinicalTrials.gov.