HIV InfectionsNCT02191293
Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®
An observational study of HIV Infections, run by Boehringer Ingelheim.
Trial summary
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes. 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?
- Viramune® tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Sep 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV treatment centres and HIV out-patient facilities
Who may be able to join
- Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)
- Women can only be included, if a test has excluded pregnancy
- Only women can be included, who use a reliable means of contraception during the observational study
Who cannot join
- Known sensitivity to Viramune or one of its excipients
- Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
- Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
- For females:
- Pregnancy
- Breast-feeding
- Insufficient or unreliable contraception
About this study
Official title: Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.
- Conditions
- HIV Infections
- Being tested
- Viramune® tablets
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viramune® tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Viramune® | Not described Receives: Drug: Viramune® tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in viral load (HIV-RNA)
Measured: Baseline, up to 36 months
Changes in CD4 cell count
Measured: Baseline, up to 36 months
Secondary outcomes (6)
Changes in body weight
Measured: Baseline, up to 36 months
Changes in general well-being assessed on a 4-point scale
Measured: Baseline, up to 36 months
Changes in lipid parameters
mg/dl
Measured: Baseline, up to 36 months
Changes in glucose
mg/dl
Measured: Baseline, up to 36 months
Changes in liver enzymes
U/l
Measured: Baseline, up to 36 months
Number of patients with adverse events
Measured: up to 36 months
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 startMay 2002
- Primary completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 228 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
- NCT02191293
- Sponsor's protocol ID
- 1100.1402
- 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
- Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)
- ClinicalTrials.gov ID
- NCT02191293
- Acronym / sponsor ID
- 1100.1402
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Sep 2006 (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.
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viramune® | – | Drug: Viramune® tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV treatment centres and HIV out-patient facilities
Key inclusion criteria (3 listed)
- Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)
- Women can only be included, if a test has excluded pregnancy
- Only women can be included, who use a reliable means of contraception during the observational study
Key exclusion criteria (7 listed)
- Known sensitivity to Viramune or one of its excipients
- Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
- Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
- For females:
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 |
|---|---|---|
| Viramune® tablets | Drug | Viramune® |
Primary outcome
Changes in viral load (HIV-RNA)
Time frame: Baseline, up to 36 months
Changes in CD4 cell count
Time frame: Baseline, up to 36 months
6 secondary outcomes
Changes in body weight
Time frame: Baseline, up to 36 months
Changes in general well-being assessed on a 4-point scale
Time frame: Baseline, up to 36 months
Changes in lipid parameters
Time frame: Baseline, up to 36 months
Changes in glucose
Time frame: Baseline, up to 36 months
Changes in liver enzymes
Time frame: Baseline, up to 36 months
Number of patients with adverse events
Time frame: up to 36 months
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.
- Related InfoLink provided by the sponsor.
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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 HIV Infections, 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 3 inclusion and 7 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?
Changes in viral load (HIV-RNA) (time frame: Baseline, up to 36 months). 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?
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.