Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals

Completed · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02251236

Run by

University of California, San Diego

People needed

14

Starts

2016-01-01

Expected to finish

2017-01-18

Last updated by the study team

2019-10-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 < 12.5 g/dL for men; < 11.5 g/dL for women;
• Platelet count < 100,000 platelets/mm3;
• AST (SGOT) or ALT (SGPT) > 1.5 x the upper limit of normal (ULN);
• Estimated GFR<70 ml/min
• Weight less than 50 kg

Where it is running

• UC San Diego AntiViral Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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