Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01694420 · ClinicalTrials.gov registry record · Phase 3
Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet
A Phase 3 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT01694420 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 33 participants.
The verdict
NCT01694420, a Phase 3 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF \[Stribild\] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and study drug (ELV/COBI/FTC/TDF) will be provided for the first 48 weeks. After week 48, clinical care but not study drug will be provided through week 96. A study participant suppressed at week 48 can continue on FDC ELV/COBI/FTC/TDF. The primary hypothesis is that once daily fixed-dose combination elvitegravir (ELV), cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) will rapidly reduce viral replication to \<50 copies RNA/ml in participants with acute HIV infection. The secondary hypotheses to be considered are 1) virologic response rates as measured by plasma HIV RNA levels will be non-inferior or superior to a historical group of participants from the PHI cohort treated with EFV/FTC/TDF, 2) compared to historical controls treated with EFV/FTC/TDF, plasma HIV RNA will decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 3) compared to historical controls treated with EFV/FTC/TDF, immune activation as measured by the proportion CD4+ and CD8+ cells expressing HLA-DR and CD38+ will decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 4)in a subset of participants samples will be obtained from compartments such as the gastrointestinal tract, and lymphoid tissues to assess changes over time in parameters such as HIV-1 RNA, immunologic responses to HIV, and tissue and anatomic reservoirs. We hypothesize that treatment with the ELV/COBI/FTC/TDF will demonstrate improved viral clearance in these compartments as compared to historical controls treated with EFV/FTC/TDF. 5) in a subset of participants who remain suppressed on therapy, resting CD4 cells with replication-competent HIV-1 (latent reservoir) will be quantitated and compared to similar
Interventions
- DRUG (FDC) ELV/COBI/FTC/TDF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01694420
The ClinicalTrials.gov registry entry for NCT01694420 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which (FDC) ELV/COBI/FTC/TDF is the first listed.
NCT01694420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01694420 about?
NCT01694420 is a clinical study titled "Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet". This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF \[Stribild\] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and study drug (ELV/COBI/FTC/TDF) will ...
What is the current status of trial NCT01694420?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2012-09. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01694420?
The interventions under investigation include: (FDC) ELV/COBI/FTC/TDF (DRUG).
Who is sponsoring clinical trial NCT01694420?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.