HIV InfectionsPhase 4NCT00703898
Durability of Nevirapine-Based Antiretroviral Regimen
A Phase 4 study testing nevirapine in people with HIV Infections, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
Trial summary
Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- nevirapine
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2004to Apr 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-infected individuals ≥15 years of age
- CD4 cell count <350 cells/mm3
- Willing to participate and give consent form
Who cannot join
- previous antiretroviral therapy
- pregnancy
- receiving a medication that has drug-drug interactions with NVP or RFP
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >5 times of upper limit of normal range
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, 11000
About this study
Official title: Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study
Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.
- Conditions
- HIV Infections
- Being tested
- nevirapine
- Keywords
- HIV, nevirapine, durability, AIDS, 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.
nevirapineDrug
Also called GPO-vir
200 mg/day twice a day
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with undetectable plasma HIV-1 viral load
Measured: 240 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startNov 2004
- Primary completionDec 2009
- Study completionApr 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bamrasnaradura Infectious Diseases Institute
- Sponsor type
- Other government
- Investigators
- Weerawat Manosuthi, Principal investigator, Bamrasnaradura Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703898
- Sponsor's protocol ID
- 0327/3619
- Status last verified
- Jun 2008
- First submitted
- 20 Jun 2008
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manosuthi W, Tantanathip P, Prasithisirikul W, Likanonsakul S, Sungkanuparph S. Durability of stavudine, lamivudine and nevirapine among advanced HIV-1 infected patients with/without prior co-administration of rifampicin: a 144-week prospective study. BMC Infect Dis. 2008 Oct 14;8:136. doi: 10.1186/1471-2334-8-136.
PubMed 18851761
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study
- ClinicalTrials.gov ID
- NCT00703898
- Acronym / sponsor ID
- 0327/3619
- Conditions
- HIV Infections
- Keywords
- HIV, nevirapine, durability, AIDS, Treatment Naïve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bamrasnaradura Infectious Diseases InstituteOther government
- Study start
- Nov 2004
- Primary completion
- Dec 2009
- Study completion
- Apr 2010
- First posted
- 24 Jun 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.
Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infected individuals ≥15 years of age
- CD4 cell count <350 cells/mm3
- Willing to participate and give consent form
Key exclusion criteria (4 listed)
- previous antiretroviral therapy
- pregnancy
- receiving a medication that has drug-drug interactions with NVP or RFP
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >5 times of upper limit of 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 |
|---|---|---|
| nevirapineAlso: GPO-vir200 mg/day twice a day | Drug | – |
Primary outcome
number of patients with undetectable plasma HIV-1 viral load
Time frame: 240 weeks
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 8 Jul 2008.
- Derived from this study: PubMed 18851761Manosuthi W, Tantanathip P, Prasithisirikul W, Likanonsakul S, Sungkanuparph S. Durability of stavudine, lamivudine and nevirapine among advanced HIV-1 infected patients with/without prior co-administration of rifampicin: a 144-week prospective study. BMC Infect Dis. 2008 Oct 14;8:136. doi: 10.1186/1471-2334-8-136.
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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.
Weerawat Manosuthi principal investigator
Bamrasnaradura Infectious Diseases Institute
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 nevirapine in people with HIV Infections, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
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 3 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 8 Jul 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 Thailand. 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.
What does the primary outcome measure?
number of patients with undetectable plasma HIV-1 viral load (time frame: 240 weeks). 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 NCT00703898, 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 8 Jul 2008.