HIV InfectionsNCT02191319
Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
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®
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Aug 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 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
- Patients suffer from HIV type 1 infection
- Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
- Patient has shown a depression of viral load before limit of detection (< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
- Patient is male or female with age greater than or equal to 18 years
- Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation
Who cannot join
- Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > five times upper limit of normal (ULN))
- Patients is hypersensitive to Viramune® or to any of its excipients
- Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
- Patients is breast-feeding
- Patient is pregnant
- Patient is a woman and does not use effective contraception
About this study
Official title: Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
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®
- 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®Drug
| Study group | Role | What they receive |
|---|---|---|
| Viramune® | Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune® Receives: Drug: Viramune® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load (HIV-RNA)
Measured: Baseline, up to 52 weeks
Change in CD4 cell count
Measured: Baseline, up to 52 weeks
Change in lipid parameters
mg/dl
Measured: Baseline, up to 52 weeks
Change in glucose
mg/dl
Measured: Baseline, up to 52 weeks
Secondary outcomes (4)
Assessment of subjective well-being
verbal rating scale
Measured: up to 52 weeks
Assessment of tolerability by physician and patients
verbal rating scale
Measured: after 52 weeks
Change in liver enzyme parameter
U/l
Measured: Baseline, up to 52 weeks
Number of patients with adverse events
Measured: up to 52 weeks
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 startJan 2002
- Primary completionAug 2004
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
- 55 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
- NCT02191319
- Sponsor's protocol ID
- 1100.1395
- 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
- Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
- ClinicalTrials.gov ID
- NCT02191319
- Acronym / sponsor ID
- 1100.1395
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Aug 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.
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®Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune® |
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 (5 listed)
- Patients suffer from HIV type 1 infection
- Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
- Patient has shown a depression of viral load before limit of detection (< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
- Patient is male or female with age greater than or equal to 18 years
- Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation
Key exclusion criteria (6 listed)
- Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > five times upper limit of normal (ULN))
- Patients is hypersensitive to Viramune® or to any of its excipients
- Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
- Patients is breast-feeding
- Patient is pregnant
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® | Drug | Viramune® |
Primary outcome
Change in viral load (HIV-RNA)
Time frame: Baseline, up to 52 weeks
Change in CD4 cell count
Time frame: Baseline, up to 52 weeks
Change in lipid parameters
Time frame: Baseline, up to 52 weeks
mg/dl
Change in glucose
Time frame: Baseline, up to 52 weeks
mg/dl
4 secondary outcomes
Assessment of subjective well-being
Time frame: up to 52 weeks
Assessment of tolerability by physician and patients
Time frame: after 52 weeks
Change in liver enzyme parameter
Time frame: Baseline, up to 52 weeks
Number of patients with adverse events
Time frame: up to 52 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 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 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 5 inclusion and 6 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 viral load (HIV-RNA) (time frame: Baseline, up to 52 weeks). 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.