HIV InfectionsPhase 4NCT00618176
Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort
A Phase 4 study testing Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP), Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) and Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP) in people with HIV Infections, run by Peking Union Medical College at 1 site in China.
Trial summary
The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP), Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) and Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Jan 2005to Sep 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis
- the subjects were antiretroviral drug-naïve
- a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml
Who cannot join
- pregnancy or breastfeeding
- anticipated nonadherence
- AIDS-defining illness within 2 weeks of entry
- white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L
- transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .
- Conditions
- HIV Infections
- Being tested
- Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP), Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP), Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)
- Keywords
- Acquired Immunodeficiency Syndrome, adverse effects, Treatment Outcome, Drug Resistance, Viral, treatment naïve
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)Drug
Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W>60Kg)125mg bid (W<60Kg) Nevirapine (NVP) 200mg bid
Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)Drug
Stavudine (d4T) 30mg bid (W>60Kg)20mg bid (W<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid
Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)Drug
Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | Not described Receives: Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) |
| A | Experimental | Not described Receives: Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP) |
| C | Experimental | Not described Receives: Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startJan 2005
- Primary completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618176
- Sponsor's protocol ID
- 2004BA719A10
- Other IDs
- 2004BA719A10
- Status last verified
- Mar 2008
- First submitted
- 5 Feb 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
Publications
Li T, Dai Y, Kuang J, Jiang J, Han Y, Qiu Z, Xie J, Zuo L, Li Y. Three generic nevirapine-based antiretroviral treatments in Chinese HIV/AIDS patients: multicentric observation cohort. PLoS One. 2008;3(12):e3918. doi: 10.1371/journal.pone.0003918. Epub 2008 Dec 12.
PubMed 19081791
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort
- ClinicalTrials.gov ID
- NCT00618176
- Acronym / sponsor ID
- 2004BA719A10
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, adverse effects, Treatment Outcome, Drug Resistance, Viral, treatment naïve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Jan 2005
- Primary completion
- Sep 2006 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) |
| A | Experimental | Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP) |
| C | Experimental | Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis
- the subjects were antiretroviral drug-naïve
- a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml
Key exclusion criteria (5 listed)
- pregnancy or breastfeeding
- anticipated nonadherence
- AIDS-defining illness within 2 weeks of entry
- white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L
- transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W>60Kg)125mg bid (W<60Kg) Nevirapine (NVP) 200mg bid | Drug | A |
| Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)Stavudine (d4T) 30mg bid (W>60Kg)20mg bid (W<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid | Drug | B |
| Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid | Drug | C |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
- Derived from this study: PubMed 19081791Li T, Dai Y, Kuang J, Jiang J, Han Y, Qiu Z, Xie J, Zuo L, Li Y. Three generic nevirapine-based antiretroviral treatments in Chinese HIV/AIDS patients: multicentric observation cohort. PLoS One. 2008;3(12):e3918. doi: 10.1371/journal.pone.0003918. Epub 2008 Dec 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP), Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) and Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP) in people with 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Mar 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618176, which also lists 1 linked publication.
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 24 Mar 2008.