HIV InfectionPhase 3NCT00158457

Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)

A Phase 3 study testing Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in people with HIV Infection, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 sites in Senegal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. This combination has already been studied in the North countries. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV)
How many people: 40 participants
Where: 2 sitesSenegal
Study dates: Jun 2004to Dec 2006
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

Documented infection with HIV-1 (ELISA- Western Blot)
Outpatient of masculine or feminine gender
In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device
No previous treatment with antiretroviral therapy
CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.
Patient has provided informed written consent
Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator

Who cannot join

Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible
Patient participating in a different clinical study
Presence of serious or developing pathology
Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)
Thrombocytopenia with platelet level under 50 000 cells /ml
Known severe renal pathology (creatinine clearance under 50 ml/min)

Show all 10Show fewer

Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification
Karnofsky under 70 percent
Opportunistic infections
Patients taking medications not recommended in the context of the protocol

Trial locations and contacts

2 sites in 1 country.

Senegal2 sites

Centre de Traitement Ambulatoire, CHU de Fann
Dakar
Service des Maladies Infectieuses, CHU de Fann
Dakar

Other trials in Senegal

About this study

Official title: Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal

Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.

Conditions: HIV Infection
Being tested: Tenofovir (TDF), Emtricitabine (FTC), Efavirenz (EFV)
Keywords: Simplification regimen, HIV infection, Once a day, Naive patients, Sub-saharian Africa, Treatment Naive
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tenofovir (TDF)Drug
Emtricitabine (FTC)Drug
Efavirenz (EFV)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population
Measured: S48

Secondary outcomes (7)

Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml
Measured: S24 and S96
Viral load evolution
Measured: S24 and S48
Genotype resistance profile evaluation failing patients
Measured: S24, S48, S96
Immune benefits of the combination
Plasma concentrations of FTC, TDF and EFV
Measured: S4
Adverse events clinic and lipids
Compliance
Measured: S48 and S96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2004Dec 2006

First posted12 Sep 2005 (estimated)
Study startJun 2004
Study completionDec 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00158457
Sponsor's protocol ID: ANRS 1207
Other IDs: IMEA 025
Status last verified: Jul 2007
First submitted: 8 Sep 2005
Last updated: 3 Jul 2007
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal
ClinicalTrials.gov ID: NCT00158457
Acronym / sponsor ID: ANRS 1207
Conditions: HIV Infection
Keywords: Simplification regimen, HIV infection, Once a day, Naive patients, Sub-saharian Africa, Treatment Naive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: French National Agency for Research on AIDS and Viral HepatitisOther government
Collaborators: Gilead Sciences, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study start: Jun 2004
Study completion: Dec 2006 (actual)
First posted: 12 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.

Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
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 (7 listed)

Documented infection with HIV-1 (ELISA- Western Blot)
Outpatient of masculine or feminine gender
In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device
No previous treatment with antiretroviral therapy
CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.

Key exclusion criteria (10 listed)

Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible
Patient participating in a different clinical study
Presence of serious or developing pathology
Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)
Thrombocytopenia with platelet level under 50 000 cells /ml

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
Tenofovir (TDF)	Drug	–
Emtricitabine (FTC)	Drug	–
Efavirenz (EFV)	Drug	–

Primary outcome

Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population
Time frame: S48

7 secondary outcomes

Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml
Time frame: S24 and S96
Viral load evolution
Time frame: S24 and S48
Genotype resistance profile evaluation failing patients
Time frame: S24, S48, S96
Immune benefits of the combination
Plasma concentrations of FTC, TDF and EFV
Time frame: S4
Adverse events clinic and lipids
Compliance
Time frame: S48 and S96

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 3 Jul 2007.

Related trials for HIV Infection

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Not yet recruiting
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Recruiting
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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.

Roland Landman study chair

IMEA- Hôpital Bichat Claude Bernard, France

Papa Salif Sow principal investigator

CHU de Fann, Dakar

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 10 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 3 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Senegal. 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?

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?

Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population (time frame: S48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00158457.

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 3 Jul 2007.