Dolutegravir plus tenofovir alafenamide as a double-drug regimen in HIV positive patients

Comparing efficacy of dolutegravir plus tenofovir alafenamide as dual-drug regimen with the standard triple-drug regimen in HIV positive patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191005044984N1

Enrollment

Registered

2019-12-21

Start date

2019-11-22

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Virologically Undetectable HIV Patients.

Interventions

Intervention 1: Intervention group: The patients' previous standard triple-drug regimen will be changed to the dual-drug regimen including dolutegravir tablet, 50 mg daily plus tenofovir alafenamide

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults older than 18 years old HIV positive patients with undetectable viral load for at least 2 years HIV positive patients with CD4 cells count >200 for at least 2 years Patients who are on first line antiretroviral therapy for at least 2 years No any mutation against INSTI or NRTI drugs Adequate adherence to treatment No any AIDS-related event (opportunistic infection or cancer)

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Concomitant viral co-infections including hepatitis B or C Existing any co-morbidity that requiring treatment which may have significant interactions with ART Renal or hepatic diseases

Design outcomes

Primary

Measure	Time frame
Virological response: Maintain HIV-RNA viral load 200 cells/mm3 during the study period. Timepoint: Control group: At baseline and weeks 24 and 48 Intervention group: At baseline and weeks 8, 24 and 48. Method of measurement: Flowcytometry.;Adverse reactions : Any new sign or symptom caused by the regimens. Timepoint: Control group: At baseline and weeks 24 and 48 Intervention group: At baseline and weeks 8, 24 and 48. Method of measurement: Interview and patient' report.;Adherence to treatment. Timepoint: Control group: At baseline and weeks 24 and 48 Intervention group: At baseline and weeks 8, 24 and 48. Method of measurement: Interview and pill count methods.	—

Measure

Time frame

Virological response: Maintain HIV-RNA viral load 200 cells/mm3 during the study period. Timepoint: Control group: At baseline and weeks 24 and 48 Intervention group: At baseline and weeks 8, 24 and 48. Method of measurement: Flowcytometry.;Adverse reactions : Any new sign or symptom caused by the regimens. Timepoint: Control group: At baseline and weeks 24 and 48 Intervention group: At baseline and weeks 8, 24 and 48. Method of measurement: Interview and patient' report.;Adherence to treatment. Timepoint: Control group: At baseline and weeks 24 and 48 Intervention group: At baseline and weeks 8, 24 and 48. Method of measurement: Interview and pill count methods.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Khalili

Tehran University of Medical Sciences

Khalilih@tums.ac.ir+98 21 6658 1598

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026