Acquired Immunodeficiency SyndromeNCT02191215
Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS
An observational study of Acquired Immunodeficiency Syndrome, run by Boehringer Ingelheim.
Trial summary
The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Nevirapine (Viramune®)
- How many people
- 442 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to May 2004
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mexican patients infected by HIV/AIDS
Who may be able to join
- diagnosis of HIV/AIDS, no age limits
- patients could be naïve to treatment or pretreated with other antiretroviral agents
Who cannot join
- Patients with known hypersensitivity to nevirapine or any other component of the product
About this study
The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Nevirapine (Viramune®)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine (Viramune®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine (Viramune®) | Not described Receives: Drug: Nevirapine (Viramune®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline, up to 90 days
Change in cluster of differentiation 4 (CD4) cell count
Measured: Baseline, up to 90 days
Change in viral load (HIV RNA)
Measured: Baseline, up to 90 days
Number of patients with adverse event
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2003
- Primary completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191215
- Sponsor's protocol ID
- 1100.1457
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS
- ClinicalTrials.gov ID
- NCT02191215
- Acronym / sponsor ID
- 1100.1457
- Conditions
- Acquired Immunodeficiency Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- May 2004 (actual)
- First posted
- 16 Jul 2014 (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 aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nevirapine (Viramune®) | – | Drug: Nevirapine (Viramune®) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mexican patients infected by HIV/AIDS
Key inclusion criteria (2 listed)
- diagnosis of HIV/AIDS, no age limits
- patients could be naïve to treatment or pretreated with other antiretroviral agents
Key exclusion criteria (1 listed)
- Patients with known hypersensitivity to nevirapine or any other component of the product
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 |
|---|---|---|
| Nevirapine (Viramune®) | Drug | Nevirapine (Viramune®) |
Primary outcome
Change in body weight
Time frame: Baseline, up to 90 days
Change in cluster of differentiation 4 (CD4) cell count
Time frame: Baseline, up to 90 days
Change in viral load (HIV RNA)
Time frame: Baseline, up to 90 days
Number of patients with adverse event
Time frame: up to 90 days
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 16 Jul 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome, run by Boehringer Ingelheim.
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 2 inclusion and 1 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 16 Jul 2014. 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?
Change in body weight (time frame: Baseline, up to 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2014.