Tenofovir DP concentrations in seminal cells and semen quality in HIV-1 infected patients receiving a TAF containing regimen

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001371-69-ES

Enrollment

Registered

2016-08-05

Start date

2016-09-30

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 positive patients

Interventions

Trade Name: Genvoya Pharmaceutical Form: Coated tablet INN or Proposed INN: ELVITEGRAVIR CAS Number: 697761-98-1 Other descriptive name:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. HIV-1 infected men = 18 years of age. 2. Be on a stable ART consisting on TDF/FTC/EVG/COBI continously for = 3 month preceeding the screening visit. 3. HIV-1 RNA VL=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Ongoing malignancy. 2. Active opportunistic infection. 3. Primary resistance to any of the ARV included in the study (genotypes without evidence of tenofovir (K65R, 3 or more TAMs including M41L, L210W), FTC (M184V/I), and EVG-associated mutations) or history of virologic failure with risk of resistance selection to any of the study drugs. 4. Chronic HBV hepatitis. 5. Any verified Grade 4 laboratory abnormality. 6. ALT or AST = 3xULN and/or bilirubin = 1.5xULN. 7. Severe renal impairment (Estimated creatinine clearance <50mL/min). 8. Severe hepatic impairment (Child-Pugh Class C).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate intracellular concentrations of tenofovir diphosphate (TFV-DP) in seminal mononuclear (SMC) cells of HIV-1 infected men receiving ART with TAF/FTC/EVG/COBI.; Secondary Objective: - To evaluate TFV concentrations in seminal plasma (SP) of HIV-1 infected men receiving ART with TAF/FTC/EVG/COBI. - To evaluate intracellular TFV-DP exposure in peripheral blood mononuclear cells (PBMC) and extracellular TFV exposure in blood plasma (BP) and to compare with drug exposure in SMC and SP. - To compare TFV-DP and TFV concentrations in SMC and SP, respectively, at baseline and after switching - To compare TFV-DP and TFV concentrations in PBMC and BP, respectively, at baselineTDF/FTC/EVG/COBI) and after switching - To evaluate HIV-1 RNA suppression in SP after switching ART . - To compare HIV-1 suppression in BP and SP at baseline and after switching - To evaluate changes in semen quality after switching ART ;Primary end point(s): TFV-DP concentrations (ng/mL) in SMC 12 weeks after switching to TAF/FTC/EVG/COBI.;Timepoint(s) of evaluation of this end point: 12 weeks after switching to TAF/FTC/EVG/COBI.	—

Measure

Time frame

Main Objective: To evaluate intracellular concentrations of tenofovir diphosphate (TFV-DP) in seminal mononuclear (SMC) cells of HIV-1 infected men receiving ART with TAF/FTC/EVG/COBI.; Secondary Objective: - To evaluate TFV concentrations in seminal plasma (SP) of HIV-1 infected men receiving ART with TAF/FTC/EVG/COBI. - To evaluate intracellular TFV-DP exposure in peripheral blood mononuclear cells (PBMC) and extracellular TFV exposure in blood plasma (BP) and to compare with drug exposure in SMC and SP. - To compare TFV-DP and TFV concentrations in SMC and SP, respectively, at baseline and after switching - To compare TFV-DP and TFV concentrations in PBMC and BP, respectively, at baselineTDF/FTC/EVG/COBI) and after switching - To evaluate HIV-1 RNA suppression in SP after switching ART . - To compare HIV-1 suppression in BP and SP at baseline and after switching - To evaluate changes in semen quality after switching ART ;Primary end point(s): TFV-DP concentrations (ng/mL) in SMC 12 weeks after switching to TAF/FTC/EVG/COBI.;Timepoint(s) of evaluation of this end point: 12 weeks after switching to TAF/FTC/EVG/COBI.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Basal and 12 weeks after switching to TAF/FTC/EVG/COBI; Secondary end point(s): - TFV concentrations (ng/mL) in SP 12 weeks after switching to TAF/FTC/EVG/COBI. - TFV-DP concentrations (ng/mL) in PBMC 12 weeks after switching to TAF/FTC/EVG/COBI. - TFV concentrations (ng/mL) in BP 12 weeks after switching to TAF/FTC/EVG/COBI. TFV and TFV-DP concentrations (ng/mL) in SP and SMC and BP nad PBMC, respectively, at baseline (whilst on TDF/FTC/EVG/COBI). - HIV-1 RNA in SP and BP at baseline (whilst on TDF/FTC/EVG/COBI) and12 weeks after switching to TAF/FTC/EVG/COBI. - Sperm quality evaluated according to World Health Organization (WHO) guidelines before and 12 weeks after switiching TAF/FTC/EVG/COBI.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Basal and 12 weeks after switching to TAF/FTC/EVG/COBI; Secondary end point(s): - TFV concentrations (ng/mL) in SP 12 weeks after switching to TAF/FTC/EVG/COBI. - TFV-DP concentrations (ng/mL) in PBMC 12 weeks after switching to TAF/FTC/EVG/COBI. - TFV concentrations (ng/mL) in BP 12 weeks after switching to TAF/FTC/EVG/COBI. TFV and TFV-DP concentrations (ng/mL) in SP and SMC and BP nad PBMC, respectively, at baseline (whilst on TDF/FTC/EVG/COBI). - HIV-1 RNA in SP and BP at baseline (whilst on TDF/FTC/EVG/COBI) and12 weeks after switching to TAF/FTC/EVG/COBI. - Sperm quality evaluated according to World Health Organization (WHO) guidelines before and 12 weeks after switiching TAF/FTC/EVG/COBI.

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Countries

Spain

Contacts

Public ContactDr. Daniel Podzamczer

Hospital Universitari de Bellvitge

dpodzamczer@bellvitgehospital.cat+3493260736672884

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 22, 2026