HIV InfectionsNCT02191332
Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen
An observational study of HIV Infections, run by Boehringer Ingelheim.
Trial summary
Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®). 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
- 147 participants
- Where
- No sites listed yet
- Study dates
- Dec 1999to Nov 2001
- 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 or female patients with HIV type 1 infection
Who cannot join
- Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
- No persons under 18
- Pregnancy and breast-feeding
- Use of oral contraceptives
- Use of drugs affecting CYP450 3A metabolism
About this study
Official title: Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen
Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).
- 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.
ViramuneDrug
| Study group | Role | What they receive |
|---|---|---|
| Viramune | Not described 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, after 26 and 52 weeks
Change in CD4 cell count
Measured: Baseline, after 26 and 52 weeks
Change in lipid status (lipodystrophy, triglycerides, cholesterol)
verbal rating scale
Measured: Baseline, after 26 and 52 weeks
Change in glucose tolerance
verbal rating scale
Measured: Baseline, after 26 and 52 weeks
Secondary outcomes (3)
Assessment of subjective well-being
verbal rating scale
Measured: up to 52 weeks
Assessment of tolerability by physician and patient
verbal rating scale
Measured: after 26 and 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 startDec 1999
- Primary completionNov 2001
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
- 147 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
- NCT02191332
- Sponsor's protocol ID
- 1100.1305
- 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
- Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen
- ClinicalTrials.gov ID
- NCT02191332
- Acronym / sponsor ID
- 1100.1305
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 1999
- Primary completion
- Nov 2001 (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.
Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viramune | – | Drug: 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 (1 listed)
- Adult male or female patients with HIV type 1 infection
Key exclusion criteria (5 listed)
- Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
- No persons under 18
- Pregnancy and breast-feeding
- Use of oral contraceptives
- Use of drugs affecting CYP450 3A metabolism
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, after 26 and 52 weeks
Change in CD4 cell count
Time frame: Baseline, after 26 and 52 weeks
Change in lipid status (lipodystrophy, triglycerides, cholesterol)
Time frame: Baseline, after 26 and 52 weeks
verbal rating scale
Change in glucose tolerance
Time frame: Baseline, after 26 and 52 weeks
verbal rating scale
3 secondary outcomes
Assessment of subjective well-being
Time frame: up to 52 weeks
Assessment of tolerability by physician and patient
Time frame: after 26 and 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.
- 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 1 inclusion and 5 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, after 26 and 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.