Status:
COMPLETED
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Gilead Sciences
University at Buffalo
Conditions:
HIV
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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/T...
Detailed Description
The proposed project will be a prospective, open-label treatment trial of 14 HIV-infected adults. Participants will be enrolled in two tracks. Track A will enroll participants who have been taking E/C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02251236
Start Date
January 1 2016
End Date
January 18 2017
Last Update
October 31 2019
Active Locations (1)
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1
UC San Diego AntiViral Research Center
San Diego, California, United States, 92103