Optimization of Antiretroviral Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-08-31

Brief Summary

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The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the first line regimen of cART in developing countries. The side effects of these drugs are related to the concentration of drugs. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced dose

Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d.

Group Type EXPERIMENTAL

Tenofovir disoproxil fumarate

Intervention Type DRUG

Oral daily

Lamivudine

Intervention Type DRUG

Oral daily

Efavirenz

Intervention Type DRUG

Oral daily

Standard dose

Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d.

Group Type ACTIVE_COMPARATOR

Tenofovir disoproxil fumarate

Intervention Type DRUG

Oral daily

Lamivudine

Intervention Type DRUG

Oral daily

Efavirenz

Intervention Type DRUG

Oral daily

Interventions

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Tenofovir disoproxil fumarate

Oral daily

Intervention Type DRUG

Lamivudine

Oral daily

Intervention Type DRUG

Efavirenz

Oral daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV antibody positive
* Chinese nationality
* Naïve to antiretroviral therapy
* Willing to start antiretroviral therapy
* Provision of written informed consent

Exclusion Criteria

* Pregnant, breastfeeding, or lactating
* Females try to get pregnant during the research period
* Subjects who allergic to any of the research drugs
* Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
* 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 \<9.0 grams/decilitre (g/dL)
* Neutrophil count \<1500/mm3
* Platelet count \<75,000/mm3
* Aspartate aminotransferase or Alanine transaminase \>3 times Upper Limit of Normal (ULN)
* Total bilirubin \>3 times Upper Limit of Normal (ULN)
* Subjects with an estimated creatinine clearance of \<90 mL/minute

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No