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Phase 3 N=74 Randomized Treatment

Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

AIDS

Enrolled (actual)
74
Serious AEs
8.1%
Results posted
Jul 2025
Primary outcome: Primary: Proportion of Patients Free of Therapeutic Failure — 47; 20; 0; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Raltegravir/3TC (Drug); EFV/TDF/FTC (Drug); ATV/r + TDF/FTC or DRV/r + TDF/FTC (Drug); DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC (Drug); EFV plus ABC/3TC or RPV/TDF/FTC (Drug); ATV/r plus ABC/3TC (Drug); DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC (Drug); RAL plus ABC/3TC (Drug); Other ART regimens (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Juan A. Arnaiz
Primary completion
Feb 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Patients Free of Therapeutic Failure
47; 20; 0; 2; 1; 0
SECONDARY
Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL)
SECONDARY
Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir
SECONDARY
Changes in Insulin Resistance (HOMA-IR)
SECONDARY
Changes in Body Fat Composition
54.13; 49.43; 28.50; 27.54; 54.09; 50.21
SECONDARY
Changes in Plasma 25-OH Vitamin D Levels
17.4; 16.7; 29.5; 26.5
SECONDARY
Changes in Estimated Glomerular Filtration Rate (CKD-EPI)
SECONDARY
Changes in CD38
SECONDARY
Changes in IL-6
SECONDARY
Changes in Sleep Quality (Pittsburgh Sleep Quality Index)
5; 4.7; 4.8; 5.1
SECONDARY
Changes in Adherence in Both Treatment Arms (Morisky-Green Test)
19; 11; 29; 13; 1; 1
SECONDARY
Changes in Total Cholesterol
189; 187; 190; 186
SECONDARY
Changes in HDL Cholesterol
48; 46; 49; 45
SECONDARY
Changes in LDL Cholesterol
120; 115; 119; 118
SECONDARY
Changes in Triglycerides
98.5; 112.0; 97.7; 100.9
SECONDARY
Changes in Bone Mineral Density
1166.1; 1211.6; 1183.0; 1247.4
SECONDARY
Changes in Urine Beta-2-microglobulin/Creatinine Ratio
672.8; 595.3; 275.7; 788.5
SECONDARY
Changes in HLA-DR
SECONDARY
Changes in High Sensitivity C-reactive Protein
SECONDARY
Changes in Mononuclear Activation SD-14
SECONDARY
Changes in Mononuclear Activation SD-163

Summary

A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression

Eligibility Criteria

Inclusion Criteria

  • Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
  • Patients seropositive for HIV-1 using standard diagnostic criteria.
  • Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
  • Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
  • Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
  • Patients who have signed informed consent to participate in the study.

Exclusion Criteria

  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Previous failure to an integrase inhibitor-containing regimen.
  • Previous failure to a 3TC or FTC-containing regimen.
  • Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
  • Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
  • Chronic hepatitis B.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02284035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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