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Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients

NCT ID: NCT00872417

Last Updated: 2009-03-31

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take the first line or second line of antiviral therapy. This study aims to set up a well-trained clinical and laboratory team in China, to explore the effects and side-effects of the first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy, cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese generic ARV regiments and effective drug concentrations and to explore primary and secondary drug resistance in China and the immune reconstitution characters of long term ARV in Chinese adult AIDS patients. This study might provide more practical and optimizing prove for the treatment guideline for resource limited areas.

Detailed Description

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Three arms will be studied in this research, 520 naive-treatment patients would be randomized to two groups, taking the generic drugs 3TC+D4T+NVP or AZT+3TC+NVP, 6 months later half of the 3TC+D4T+NVP group will switch to AZT+3TC+NVP, in order to observe the efficiency and safety of the first line drugs. Arm 2 will recruit 100 patients who are taking ARV for about three years already. Arm 3 will recruit 150 patients who have a Viral load of more than 1000 copies/ml, i.e., drug resistance. The second line drug 3TC+TDF+LPV/RTV will given to them and the safety and efficiency will be observed. All patients should be explored in terms of the clinical features, drugs side-effects, and immunological and viral response. The drug concentration and the metabolism changes would be explored also. Also the immune reconstitution will be studied for all patients. This study will be the first large-scale, multicentered, randomised, prospective ARV therapy study in China for HIV/AIDs patients. The result would provide proves for further practical antiviral therapy for China or other resource limited countries.

Conditions

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Acquired Immune Deficiency Syndrome HIV Infections

Keywords

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HIV/AIDS antiretroviral therapy immune reconstitution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment-naive

To explore the efficiency and safety of generic antiretroviral drugs for 520 treatment-naive HIV/AIDS patients

Group Type EXPERIMENTAL

first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)

Intervention Type DRUG

use the generic regimens: 3TC+NVP+D4T or 3TC+NVP+AZT to initiate the ARV therapy, after 6 months, half of the group 3TC+NVP+D4T patients switch to the the treatment of 3TC+NVP+AZT

TREATMENT-EXPERIENCED

To explore the long term ARV of treatment-experienced patients who have no sign of drug resistance; to explore the long term efficiency and safety and drug sife effects of ARV in HIV/AIDS patients. These patients have taken ARV for approximately 3 years already.

Group Type NO_INTERVENTION

No interventions assigned to this group

drug resistance

To explore the second line drugs for those drug resistance patients

Group Type EXPERIMENTAL

second line ARV therapy (3TC+TDF+LPV/RTV)

Intervention Type DRUG

Use 3TC+TDF+LPV/RTV to treat those drug resistance patients, to explore the efficiency and safety of the second line ARV available in China

Interventions

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first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)

use the generic regimens: 3TC+NVP+D4T or 3TC+NVP+AZT to initiate the ARV therapy, after 6 months, half of the group 3TC+NVP+D4T patients switch to the the treatment of 3TC+NVP+AZT

Intervention Type DRUG

second line ARV therapy (3TC+TDF+LPV/RTV)

Use 3TC+TDF+LPV/RTV to treat those drug resistance patients, to explore the efficiency and safety of the second line ARV available in China

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age between 18-65 years
* HIV seropositive and confirmed by western blot
* antiretroviral therapy naive for arm 1
* CD4 cell count \< 350/mm3
* good adherence and follow up in the same place

Exclusion Criteria

* pregnancy and breastfeeding
* AIDS defining illness or any infectious disease occured in one month but still unstable within 14 days
* with WBC \< 2000/ul, neutrophil count \< 1000/ul, hemoglobin \< 9 g/dl, platelet count \< 75000/ul, amylase \> 2 ULN, transaminase or alkaline phosphatase or total bilirubin \> 2 ULN, creatinine \> 2 ULT.
* present acute or chronic pancreatitis
* intravenous drug user
* peripheral nephropathy
* severe nephropathy or mental disorder
* severe gastral ulcer
* heart or brain arthrosclerosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role collaborator

Peking Union Medical College

OTHER

Sponsor Role lead

Responsible Party

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Peking Union Medical College Hospital

Principal Investigators

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Tai sheng LI, M.D

Role: STUDY_CHAIR

PUMCH

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Tai sheng LI, M.D

Role: CONTACT

Phone: 00861065295086

Email: [email protected]

Facility Contacts

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Yang HAN

Role: primary

References

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Fan H, Guo F, Hsieh E, Chen WT, Lv W, Han Y, Xie J, Li Y, Song X, Li T. Incidence of hypertension among persons living with HIV in China: a multicenter cohort study. BMC Public Health. 2020 Jun 1;20(1):834. doi: 10.1186/s12889-020-08586-9.

Reference Type DERIVED
PMID: 32487185 (View on PubMed)

Han Y, Li Y, Xie J, Qiu Z, Li Y, Song X, Zhu T, Li T. Week 120 efficacy of tenofovir, lamivudine and lopinavir/r-based second-line antiretroviral therapy in treatment-experienced HIV patients. PLoS One. 2015 Mar 30;10(3):e0120705. doi: 10.1371/journal.pone.0120705. eCollection 2015.

Reference Type DERIVED
PMID: 25821963 (View on PubMed)

Cao Y, Han Y, Xie J, Cui Q, Zhang L, Li Y, Li Y, Song X, Zhu T, Li T. Impact of a tenofovir disoproxil fumarate plus ritonavir-boosted protease inhibitor-based regimen on renal function in HIV-infected individuals: a prospective, multicenter study. BMC Infect Dis. 2013 Jul 1;13:301. doi: 10.1186/1471-2334-13-301.

Reference Type DERIVED
PMID: 23815472 (View on PubMed)

Kou H, Du X, Li Y, Xie J, Qiu Z, Ye M, Fu Q, Han Y, Zhu Z, Li T. Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients. PLoS One. 2013;8(1):e52950. doi: 10.1371/journal.pone.0052950. Epub 2013 Jan 24.

Reference Type DERIVED
PMID: 23359265 (View on PubMed)

Wang H, Li Y, Zhang C, Han Y, Zhang X, Zhu T, Li T. Immunological and virological responses to cART in HIV/HBV co-infected patients from a multicenter cohort. AIDS. 2012 Sep 10;26(14):1755-63. doi: 10.1097/QAD.0b013e328355ced2.

Reference Type DERIVED
PMID: 22614885 (View on PubMed)

Other Identifiers

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PUMCH

Identifier Type: -

Identifier Source: secondary_id

CACT0810

Identifier Type: -

Identifier Source: org_study_id