HIV InfectionsNCT00100594
Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected People in Wenxi County, Shanxi Province, China
A study testing Efavirenz and Lamivudine/zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
The purpose of this study is to determine the safety, effectiveness, and tolerability of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected people in Wenxi County, Shanxi Province, China. 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?
- Efavirenz and Lamivudine/zidovudine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2005to May 2007
- Phase
- Interventional
- 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
- HIV infected
- Antiretroviral naive
- CD4 count of less than 350 cells/mm3 within 30 days of study entry
- Willing to use acceptable forms of contraception
- Willing to stay in the study area for the duration of the study
- Willing to not consume traditional Chinese medicines for the duration of the study
- Willing to adhere to the follow-up study schedule
Who cannot join
- Presence of an acute serious medical illness within 14 days prior to study entry. Participants with recently diagnosed opportunistic infections (except tuberculosis [TB]) and are stable on therapy for more than 30 days are eligible.
- Current pancreatitis
- Require certain medications
- Pregnant or breastfeeding
About this study
Official title: A Feasibility Study of Lamivudine/Zidovudine (3TC/ZDV) Plus Efavirenz (EFV) as Initial Therapy of HIV-1 Infected Patients in a Rural Area of China
The purpose of this study is to determine the safety, effectiveness, and tolerability of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected people in Wenxi County, Shanxi Province, China.
Read the detailed description
HIV infection in China has reached epidemic proportions, especially in poor rural communities. Among the infected are former commercial plasma donors who became infected through contaminated blood collection equipment. This study will evaluate the safety, efficacy, and tolerability of an antiretroviral (ARV) regimen given to treatment-naive HIV infected adults. Participants will be recruited in Wenxi County, Shanxi Province.
This study will last 1 year. At study entry, all study participants will be given an ARV regimen consisting of lamivudine/zidovudine twice daily and efavirenz once daily. There will be 11 study visits; a physical exam, blood collection, and vital signs measurement will occur at all study visits. Participants will also receive safe sex and adherence counseling at all visits. Participants will be asked to complete an adherence questionnaire and will have their pills counted at most visits.
- Conditions
- HIV Infections
- Being tested
- Efavirenz, Lamivudine/zidovudine
- Keywords
- Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
Lamivudine/zidovudineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality
treatment-limiting toxicity, defined by any participant in whom treatment is permanently discontinued according to toxicity guidelines
Secondary outcomes (3)
Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks
adherence, defined by continuous and dichotomous measure
ARV drug resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2007
- Study completionMay 2007
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Yunzhen Cao, MD, Study chair, The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100594
- Sponsor's protocol ID
- CIPRA CH 004
- Status last verified
- Feb 2011
- First submitted
- 3 Jan 2005
- Last updated
- 23 Feb 2011
- Results posted
- No
Publications
Wu Z, Rou K, Cui H. The HIV/AIDS epidemic in China: history, current strategies and future challenges. AIDS Educ Prev. 2004 Jun;16(3 Suppl A):7-17. doi: 10.1521/aeap.16.3.5.7.35521.
PubMed 15262561
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Lamivudine/Zidovudine (3TC/ZDV) Plus Efavirenz (EFV) as Initial Therapy of HIV-1 Infected Patients in a Rural Area of China
- ClinicalTrials.gov ID
- NCT00100594
- Acronym / sponsor ID
- CIPRA CH 004
- Conditions
- HIV Infections
- Keywords
- Treatment Naive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- May 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 4 Jan 2005 (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 the safety, effectiveness, and tolerability of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected people in Wenxi County, Shanxi Province, China.
Detailed description
HIV infection in China has reached epidemic proportions, especially in poor rural communities. Among the infected are former commercial plasma donors who became infected through contaminated blood collection equipment. This study will evaluate the safety, efficacy, and tolerability of an antiretroviral (ARV) regimen given to treatment-naive HIV infected adults. Participants will be recruited in Wenxi County, Shanxi Province.
This study will last 1 year. At study entry, all study participants will be given an ARV regimen consisting of lamivudine/zidovudine twice daily and efavirenz once daily. There will be 11 study visits; a physical exam, blood collection, and vital signs measurement will occur at all study visits. Participants will also receive safe sex and adherence counseling at all visits. Participants will be asked to complete an adherence questionnaire and will have their pills counted at most visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV infected
- Antiretroviral naive
- CD4 count of less than 350 cells/mm3 within 30 days of study entry
- Willing to use acceptable forms of contraception
- Willing to stay in the study area for the duration of the study
Key exclusion criteria (4 listed)
- Presence of an acute serious medical illness within 14 days prior to study entry. Participants with recently diagnosed opportunistic infections (except tuberculosis [TB]) and are stable on therapy for more than 30 days are eligible.
- Current pancreatitis
- Require certain medications
- Pregnant or breastfeeding
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 |
|---|---|---|
| Efavirenz | Drug | – |
| Lamivudine/zidovudine | Drug | – |
Primary outcome
Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality
treatment-limiting toxicity, defined by any participant in whom treatment is permanently discontinued according to toxicity guidelines
3 secondary outcomes
Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks
adherence, defined by continuous and dichotomous measure
ARV drug resistance
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 23 Feb 2011.
- Background: PubMed 15262561Wu Z, Rou K, Cui H. The HIV/AIDS epidemic in China: history, current strategies and future challenges. AIDS Educ Prev. 2004 Jun;16(3 Suppl A):7-17. doi: 10.1521/aeap.16.3.5.7.35521.
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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.
Yunzhen Cao, MD study chair
The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College
Questions about this trial
What is this clinical trial studying?
A study testing Efavirenz and Lamivudine/zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 7 inclusion and 4 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 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
What does the primary outcome measure?
Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality. The study lists 2 primary outcomes in all. 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 NCT00100594, 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 23 Feb 2011.