Women in Dual With Dolutegravir

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05735535
• Other study ID #: 4455
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2023
• Est. completion date: September 15, 2025

Study information

• Verified date: January 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 290
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Antiviral Agents
two-drug one-pill once day

Locations

Country	Name	City	State
Italy	Fondazione PoliclinicoAgostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	96 weeks