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AzTrials

Acquired Immune Deficiency SyndromePhase 4NCT00872417

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

A Phase 4 study testing first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT) and second line ARV therapy (3TC+TDF+LPV/RTV) in people with Acquired Immune Deficiency Syndrome and HIV Infections, run by Peking Union Medical College at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT) and second line ARV therapy (3TC+TDF+LPV/RTV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
1 siteChina
Study dates
Mar 2009to Dec 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • severe nephropathy or mental disorder
  • severe gastral ulcer
  • heart or brain arthrosclerosis

Trial locations and contacts

1 site in 1 country.

Tai sheng LI, M.D contact

00861065295086

litsh@263.net

China1 site

  • Peking Union Medical College Hospital

    Beijing, 100730

    Yang HAN, hanyang@pumch.cn

    Wei LU, M.D

Other trials in China

About this study

Official title: Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients

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.

Read the detailed description

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.

Being tested
first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT), second line ARV therapy (3TC+TDF+LPV/RTV)
Keywords
HIV/AIDS, antiretroviral therapy, immune reconstitution
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT00872417
Study groupRoleWhat they receive
Treatment-naiveExperimentalTo explore the efficiency and safety of generic antiretroviral drugs for 520 treatment-naive HIV/AIDS patients
Receives: Drug: first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)
TREATMENT-EXPERIENCEDNo interventionTo 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.
drug resistanceExperimentalTo explore the second line drugs for those drug resistance patients
Receives: Drug: second line ARV therapy (3TC+TDF+LPV/RTV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To set up a platform of antiviral therapy network all of CHINA, to obtain evidence to make first line or second line ARV treatment strategy for HIV/AIDS patients in resource limited areas.

    Measured: two years

Secondary outcomes (1)

  1. Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result.

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00872417
Sponsor's protocol ID
CACT0810
Other IDs
PUMCH
Status last verified
Mar 2009
First submitted
30 Mar 2009
Last updated
31 Mar 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32487185

  • 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.

    PubMed 25821963

  • 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.

    PubMed 23815472

  • 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.

    PubMed 23359265

  • 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.

    PubMed 22614885

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT) and second line ARV therapy (3TC+TDF+LPV/RTV) in people with Acquired Immune Deficiency Syndrome and HIV Infections, run by Peking Union Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tai sheng LI, M.D (00861065295086, litsh@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To set up a platform of antiviral therapy network all of CHINA, to obtain evidence to make first line or second line ARV treatment strategy for HIV/AIDS patients in resource limited areas. (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00872417, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2009.

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