Hiv Infection With Antiretroviral Therapy IndicationPhase 3NCT00199979
Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
A Phase 3 study testing Nevirapine in people with Hiv Infection With Antiretroviral Therapy Indication and CD4 Below 350/µL or Below 15%, run by MEDEX at 1 site in France.
Trial summary
The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv Infection With Antiretroviral Therapy Indication, CD4 Below 350/µL or Below 15%
- What is being tested?
- Nevirapine
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Jun 2008
- Phase
- Phase 3
- 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
Who may be able to join
- HIV-1 infection, confirmed by a western-blot assay, at least 6 months after primary infection
- Age > or equal to 18 years of age
- No prior antiretroviral treatment
- Karnofsky superior to 60%
- CD4 T cells < 350/µL (2 measures, with at least a 1-month interval) in women, study will be proposed when CD4 cell count is below 250/µL, as nevirapine liver toxicity increases (X10) when CD4 are > 250/µL
- Written informed consent
Who cannot join
- HIV-2 infection or co-infection
- Prior antiretroviral treatment
- Intolerance, or contraindication to investigational drugs
- Pregnant or breast-feeding woman, or plan to become pregnant
- Active untreated opportunistic infections (AIDS-defining illness, category C, CDC, 1993), or malignancies requiring cytotoxic chemotherapy
- Biological criteria: hemoglobin < 10 G/DL, neutrophil count < 1000/µL, platelets < 50000/µL, creatinine > 2N, ASAT or ALAT > 2.5N, bilirubin > 2N, hypophosphatemia
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- Prevision of poor adherence
- HBC co-infection (Ag Hbs positive) or HVC co-infection (positive HCV PCR)
- Liver failure, alcohol abuse
- Treatment administration not recommended with investigational drugs
- Interferon, interleukin, or HIV vaccine treatment
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cisih, Clinique Medical A, Hopitaux Universitaires
Strasbourg, Alsace, 67091
REY DAVID, M.D, 0388116333 ext. 33, david.rey@chru-strasbourg.fr
REY DAVID, M.D
About this study
Official title: Multicenter, Randomized, Open-Label Trial, Assessing the Efficacy of Zidovudine, Lamivudine and Nevirapine Combination Administered Twice Daily, Versus the Association of Tenofovir, Lamivudine and Nevirapine, Once Daily, in Antiretroviral Naive HIV-1 Infected Patients
The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.
Read the detailed description
96-week antiviral efficacy of tenofovir + lamivudine + nevirapine, once daily, versus a reference antiretroviral treatment given twice daily (zidovudine/lamivudine + nevirapine)
- Being tested
- Nevirapine
- Keywords
- Antiretroviral Therapy, Nevirapine, HIV Viral Load, Adherence, Quality of Life, Resistance Mutations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the antiviral efficacy of AZT, 3TC, and NVP combination, in two doses per day, to the association of TDF, 3TC, and NVP, once a day, in antiretroviral naive HIV-1-infected patients (plasma viral load below 400 copies/ml at 96 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiv Infection With Antiretroviral Therapy IndicationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- MEDEX
- Sponsor type
- University, hospital or other
- Investigators
- REY MR DAVID, M.D, Principal investigator, CISIH CHRU STRASBOURG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199979
- Sponsor's protocol ID
- DAUFIN
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 16 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-Label Trial, Assessing the Efficacy of Zidovudine, Lamivudine and Nevirapine Combination Administered Twice Daily, Versus the Association of Tenofovir, Lamivudine and Nevirapine, Once Daily, in Antiretroviral Naive HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00199979
- Acronym / sponsor ID
- DAUFIN
- Keywords
- Antiretroviral Therapy, Nevirapine, HIV Viral Load, Adherence, Quality of Life, Resistance Mutations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants
- Lead sponsor
- MEDEXUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jun 2008
- First posted
- 20 Sep 2005 (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 study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.
Detailed description
96-week antiviral efficacy of tenofovir + lamivudine + nevirapine, once daily, versus a reference antiretroviral treatment given twice daily (zidovudine/lamivudine + nevirapine)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1 infection, confirmed by a western-blot assay, at least 6 months after primary infection
- Age > or equal to 18 years of age
- No prior antiretroviral treatment
- Karnofsky superior to 60%
- CD4 T cells < 350/µL (2 measures, with at least a 1-month interval) in women, study will be proposed when CD4 cell count is below 250/µL, as nevirapine liver toxicity increases (X10) when CD4 are > 250/µL
Key exclusion criteria (12 listed)
- HIV-2 infection or co-infection
- Prior antiretroviral treatment
- Intolerance, or contraindication to investigational drugs
- Pregnant or breast-feeding woman, or plan to become pregnant
- Active untreated opportunistic infections (AIDS-defining illness, category C, CDC, 1993), or malignancies requiring cytotoxic chemotherapy
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 | Drug | – |
Primary outcome
To compare the antiviral efficacy of AZT, 3TC, and NVP combination, in two doses per day, to the association of TDF, 3TC, and NVP, once a day, in antiretroviral naive HIV-1-infected patients (plasma viral load below 400 copies/ml at 96 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2005.
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.
REY MR DAVID, M.D principal investigator
CISIH CHRU STRASBOURG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevirapine in people with Hiv Infection With Antiretroviral Therapy Indication and CD4 Below 350/µL or Below 15%, run by MEDEX at 1 site in France.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Dec 2005. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact REY DAVID, M.D (0388116451 ext. 33, david.rey@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the antiviral efficacy of AZT, 3TC, and NVP combination, in two doses per day, to the association of TDF, 3TC, and NVP, once a day, in antiretroviral naive HIV-1-infected patients (plasma viral load below 400 copies/ml at 96 weeks).. 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 Dec 2005.