Phase 4
N=61
Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01778413 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks. — 30; 31; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ATRIPLA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anna Cruceta
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks. |
30; 31; 0; 0 | — |
| SECONDARY The Proportion of Patients With Ultrasensitive Viral Load (<1 Copy / mL) After 24 Weeks. |
— | — |
| SECONDARY The Change From Baseline to 24 Weeks in the Viral Reservoir in Peripheral Blood Mononuclear Cells |
— | — |
| SECONDARY Immunological |
— | — |
| SECONDARY Changes in Plasma Levels of Efavirenz. |
— | — |
| SECONDARY Changes in Sleep Quality (Pittsburgh Sleep Quality Index). |
— | — |
| SECONDARY General Safety (Report Adverse Events, Serious Adverse Events and Treatment Discontinuation Due to Adverse Events) |
— | — |
| SECONDARY Changes in Plasma Levels of Vitamin D. |
— | — |
| SECONDARY Changes in Lipid Profile. |
— | — |
| SECONDARY Changes in Estimated Glomerular Filtration Rate. |
— | — |
Summary
The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.
Eligibility Criteria
Inclusion Criteria
- Adults (≥ 18 years)
- HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years.
- Standard plasma viral load below the limit of detection for at least 2 years.
- CD4 count above 350/mm3 at the time of the consideration for the study.
- Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug.
- Patients should be given written informed consent
- In the opinion of the investigator, be able to follow the design of the protocol visits
Exclusion Criteria
- Patients who have experienced virologic failure prior to any antiretroviral regimen
- Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine
- Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study
- Any contraindication to study drug
- Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient
- Uncontrolled preexisting psychiatric illness
- Any current sign of alcoholism or other drug use.
Data sourced from ClinicalTrials.gov (NCT01778413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.