Doravirine and Weight Gain in Antiretroviral Naive

NCT05457530 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 60160
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.

Conditions

Body Weight Changes; Human Immunodeficiency Virus; ART; Obesity; Minority Health; BMD; Metabolic Syndrome; Fasting

Keywords

Treatment Naive; African American Women; Hispanic Women; Fasting Glucose; Fasting Insuline; Negative pregnancy test; 18 years or older

Outcome Measures

Primary Outcomes (3)

• Change from Baseline of BMI after Initiation of ART Therapy at Week 48

  Comparison of weight and height is collected prior to, and during ART to determine baseline and changes of BMI (kg/m2) on ART.

  Week 48

• Change of BMI Category after Initiation of ART Therapy at Week 48

  Comparison of participants w/ \>10% weight change in the study arms. BMI categories: underweight (\<18.5) or normal weight (18.5 - 25) or overweight (25 - 30) or obese (\>30); or from overweight to obese.

  Week 48

• Change in Regional Lean and Body Mass

  Whole body Dual-energy X-ray absorptiometry (DEXA) scan (Hologic, QDR 4500A) will measure changes between study arms.

  Week 48

Study Arms (3)

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

ACTIVE COMPARATOR

Participants to receive DOR/3TC/TDF tablet once daily for 48 weeks

Drug: DOR/3TC/TDF

Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate

ACTIVE COMPARATOR

Participants to receive DOR + FTC/TAF tablets once daily for 48 weeks

Combination Product: DOR + FTC/TAF

Bictegravir/Emtricitibine/Tenofovir alafenamide

ACTIVE COMPARATOR

Participants to receive BIC/FTC/TAF tablet once daily for 48 weeks

Drug: BIC/FTC/TAF

Interventions

DOR/3TC/TDF DRUG

100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF

Also known as: Delstrigo

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

DOR + FTC/TAF COMBINATION_PRODUCT

100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF)

Also known as: Pifeltro + Descovy

Doravirine + Emtricitibine/Tenofovir alafenamide Fumerate

BIC/FTC/TAF DRUG

Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg

Also known as: Biktarvy

Bictegravir/Emtricitibine/Tenofovir alafenamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older;
• No prior exposure to antiretroviral therapy for \>7 days prior to study entry;
• Plasma HIV1 RNA concentration \>/=5000 copies/mL;
• CD4 T cell count \>/=200 cells/µL.
• For persons capable of becoming pregnant, negative serum or urine pregnancy test within 45 days prior to entry
• Ability and willingness of participant or legal guardian/representative to provide informed consent

You may not qualify if:

• Evidence of resistance to DOR, TDF, 3TC/FTC or BIC.
• Creatinine clearance \<60 mL/min
• Use of weight loss agents or plans to initiate weight loss program (diet or exercise-based)
• Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation

Sponsors & Collaborators

• Prism Health North Texas: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Prism Health North Texas

Dallas, Texas, 75208, United States

Location

MeSH Terms

Conditions

Body Weight Changes; Acquired Immunodeficiency Syndrome; Obesity; Metabolic Syndrome; Fasting

Interventions

Receptors, Opioid, delta; doravirine; emtricitabine tenofovir alafenamide; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Receptors, Opioid; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Neuropeptide; Receptors, Neurotransmitter; Receptors, Peptide

Study Officials

• Roger Bedimo

  Prism Health North Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: July 14, 2022
• Study Start: August 1, 2022
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)