search
Back to results

Women in Dual With Dolutegravir (Woddol4455)

Primary Purpose

HIV Infections

Status
Not yet recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Antiviral Agents
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female individuals HIV-1 documented infection Age > 18 years Being on an effective (pVL < 50 copies/ml) three-drug cART regimen containing tenofovir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TDF/F/PI/c; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) for at least 3 months before the screening. Two consecutive HIV-1 RNA determinations below the determination threshold before enrollment are required No known allergy or intolerance to NRTIs, NNRTIs or INSTIs Women of childbearing potential will be required to adopt an effective birth control system throughout the study period Subjects able to comply with the protocol requirements Informed consent signed Exclusion Criteria: Having failed virologically any previous ART regimen · Evidence of any 3TC (presence of M184V/I or K65R/E/N) or INSTI resistance · Having ever been treated with mono or dual ARV therapies subsequently intensified to three-drug cART regimen Pregnancy or breast-feeding or not willing to use effective contraception if they are of child bearing potential An active malignancy or OI requiring active treatment (prophylactic regimens are allowed) · HBV infection · A life expectancy < 2 years

Sites / Locations

  • Fondazione PoliclinicoAgostino Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3TC/DTG

TDF Regimen

Arm Description

·To evaluate efficacy of switching to a two-drug one-pill regimen with DTG/3TC

comparision arm to maintaining the three-drugs regimen in women currently receiving any three-drug regimen containing Tenovofir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) who are virologically suppressed.

Outcomes

Primary Outcome Measures

HIV-RNA < 50 copies/ml
Proportion of patients maintaining a HIV-RNA < 50 copies/ml according to FDA snapshot algorithm at 48 weeks according to an ITT NC = failure approach in which all randomized patients will be included and considered failures independently of the reason they did not complete the follow-up.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
September 11, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT05735535
Brief Title
Women in Dual With Dolutegravir
Acronym
Woddol4455
Official Title
Multi-center Study to Evaluate Virological Efficacy, Safety Tolerability, Drug Exposure and Patients' Reported Outcomes Over 48 Weeks Following Randomization to 2-drug Therapy With DTG/3TC FDC or Continuing Current Antiretroviral Tenofovir (TAF or TDF)-Containing Regimen (T-CR) in HIV-1 Infected Virologically Suppressed
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 15, 2025 (Anticipated)
Study Completion Date
September 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Strategies for optimizing antiretroviral treatment in virologically suppressed patients are still a major challenge in the field of HIV. These strategies include improving the toxicity and tolerability of drugs in the short and long term, such as replacing toxic agents with safer ones or reducing the number of drugs in the combination. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir (TFV) that is converted intracellularly to the active form, resulting in higher concentrations of TFV diphosphate in circulating lymphocytes than those obtained with tenofovir disoproxil fumarate (TDF). Because of these pharmacokinetic properties, TAF results in 91% lower plasma exposure to TFV. Phase 3 studies have established the virological noninferiority of TAF to TDF, with a lower frequency of renal and bone adverse events. Replacing TDF with TAF may be a safe and effective option to reduce toxicities when switching from one ARV strategy to another and, to date, could represent the optimization of a three-drug regimen. Dolutegravir (DTG) is a potent INSTI that exhibits rapid and potent viral load reduction and a high barrier to resistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3TC/DTG
Arm Type
Experimental
Arm Description
·To evaluate efficacy of switching to a two-drug one-pill regimen with DTG/3TC
Arm Title
TDF Regimen
Arm Type
Active Comparator
Arm Description
comparision arm to maintaining the three-drugs regimen in women currently receiving any three-drug regimen containing Tenovofir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) who are virologically suppressed.
Intervention Type
Drug
Intervention Name(s)
Antiviral Agents
Intervention Description
two-drug one-pill once day
Primary Outcome Measure Information:
Title
HIV-RNA < 50 copies/ml
Description
Proportion of patients maintaining a HIV-RNA < 50 copies/ml according to FDA snapshot algorithm at 48 weeks according to an ITT NC = failure approach in which all randomized patients will be included and considered failures independently of the reason they did not complete the follow-up.
Time Frame
96 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female individuals HIV-1 documented infection Age > 18 years Being on an effective (pVL < 50 copies/ml) three-drug cART regimen containing tenofovir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TDF/F/PI/c; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) for at least 3 months before the screening. Two consecutive HIV-1 RNA determinations below the determination threshold before enrollment are required No known allergy or intolerance to NRTIs, NNRTIs or INSTIs Women of childbearing potential will be required to adopt an effective birth control system throughout the study period Subjects able to comply with the protocol requirements Informed consent signed Exclusion Criteria: Having failed virologically any previous ART regimen · Evidence of any 3TC (presence of M184V/I or K65R/E/N) or INSTI resistance · Having ever been treated with mono or dual ARV therapies subsequently intensified to three-drug cART regimen Pregnancy or breast-feeding or not willing to use effective contraception if they are of child bearing potential An active malignancy or OI requiring active treatment (prophylactic regimens are allowed) · HBV infection · A life expectancy < 2 years
Facility Information:
Facility Name
Fondazione PoliclinicoAgostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Cingolani
Phone
00390630154945
Email
antonella.cingolani@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Women in Dual With Dolutegravir

We'll reach out to this number within 24 hrs