N/A
Completed N=14
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
Source: ClinicalTrials.gov NCT02251236 ↗Enrolled (actual)
14
Serious AEs
14.3%
Results posted
Oct 2019
Primary outcomePrimary: Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline — 4.3; 2.72 ng/mL
Summary
The project will have two tracks, one for participants who are currently taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track B).
Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF) STR** (if available) for 24 weeks.
*Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate.
**Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline |
4.3; 2.72 | — |
| PRIMARY Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24 |
5.90; 3.09 | — |
| PRIMARY Concentration of Tenofovir in Cerebrospinal Fluid at Baseline |
3.03; 0.49 | — |
| PRIMARY Concentration of Tenofovir in Cerebrospinal Fluid at Week 24 |
0.507; 0.481 | — |
Eligibility Criteria
Inclusion Criteria
- Adult men or women aged 18-60 years. Able and willing to provide informed consent.
- Presence of HIV-1 infection as documented by a licensed ELISA test kit and confirmed by Western blot or HIV RNA.
- Track A (Currently taking E/C/F/TDF or E/C/F/TAF): Taking E/C/F/TDF or E/C/F/TAF for at least 3 months prior to screening and undetectable plasma HIV-1 RNA (≤ 40 copies/mL)
- Track B (Currently not taking ART): Off ART for at least 3 months. Prior exposure to TDF and FTC will be allowed but subjects must not have primary genotypic drug resistance mutations to elvitegravir, tenofovir, or emtricitabine (see Exclusion Criteria)
- Plasma HIV-1 RNA ≥ 5, 000c/mL and CD4+ T-cell count ≥200cells/mm3.
Exclusion Criteria
- Track B: Presence of primary drug resistance mutations for EVG, tenofovir, or emtricitabine.
- Use of drugs of abuse or alcohol which would interfere with adherence or completion of this study. While on-study, subjects will be instructed not to consume alcohol for 48 hours prior to pharmacokinetic sampling days.
- Pregnancy or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study entry and day of entry.
- Chronic, severe, or other medical conditions that, in the opinion of the investigator, would interfere with the subjects ability to participate in the protocol.
- Use of prohibited protocol-specified drugs, prescription or over-the-counter, within 14 days prior to study entry.
- Bleeding abnormality or other contraindication to lumbar puncture.
- Moderate or severe cognitive impairment by history or based on Montreal Cognitive Assessment.
- Hepatitis B surface antigen (HBsAg) positive (Positive anti-HBs antibody and negative HBsAg results are acceptable)
- Hepatitis C antibody (HCV Ab) positive
- Laboratory parameters documented within 21 days prior to study entry that would increase the risk for adverse events:
- Hemoglobin 1.5 x the upper limit of normal (ULN);
- Estimated GFR<70 ml/min
- Weight less than 50 kg
Data sourced from ClinicalTrials.gov (NCT02251236). 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. Informational only — not medical advice.