ART Drug Dosage Adjustment in HIV-infected Population

NCT02632474 | Completed Phase 4

• 1 other identifier: FSCII-ART-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.

Conditions

HIV Infections

Keywords

HIV Infections; Tenofovir; Efavirenz

Outcome Measures

Primary Outcomes (1)

• HIV viral load

  48 weeks

Secondary Outcomes (1)

• CD4 Count

  48 weeks

Other Outcomes (1)

• Drug Plasma Concentration

  Day 7,14,21,28

Study Arms (1)

Low-dose

EXPERIMENTAL

Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)

Drug: Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)

Interventions

Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV) DRUG

The first 2 weeks, TDF (300 mg) + 3-TC (300 mg) + EFV (400 mg); week 3, TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg ); week 4, TDF (150 mg) + 3-TC (300 mg) + EFV (400 mg).From week5, if the HIV viral load decreased as expected or no rebound, use TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg) until study complete; if the viral load increases, switch to the standard treatment regimen: TDF (300 mg) + 3-TC (300 mg) + EFV (600 mg).

Low-dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV antibody positive
• HIV RNA below 10\*E5 copies/ml
• CD4 T cell count above 200 cells/ml
• Provision of written informed consent

You may not qualify if:

• HIV genotyping resistant to investigating drug
• Pregnant, breastfeeding, or lactating
• Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
• Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
• Laboratory blood values:
• Haemoglobin \<7.0 grams/decilitre (g/dL)
• Neutrophil count \<500/mm3
• Platelet count \<50,000/mm3
• Aspartate aminotransferase or Alanine transaminase \>5 times Upper Limit of Normal (ULN)
• Subjects with an estimated creatinine clearance of \<50 mL/minute

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

CN (1)