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Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

NCT ID: NCT00196599

Last Updated: 2005-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2004-09-30

Brief Summary

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In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.

Detailed Description

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In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a CD4 count over 100/mm3, a HIV RNA over 5,000 copies/ml and antiretroviral naive, take the once daily combination of FTC, ddI, efavirenz during 24 weeks. The primary end-point is the viral success maintained from 12 weeks until 24 weeks. Secondary end-point is the adherence to the association and safety.

The trial is prolonged during a total of 72 weeks.

Conditions

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HIV Infections Antiretroviral Naive

Keywords

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HIV infections Reverse Transcriptase Inhibitors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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emtricitabine, FTC (drug)

Intervention Type DRUG

didanosine, ddI (drug)

Intervention Type DRUG

efavirenz (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV infection
* Antiretroviral naive
* CD4 cell count over 100/mm3
* Plasma HIV RNA load over 5,000 copies/mL
* Signed written informed consent

Exclusion Criteria

* Hepatitis B infection
* Pregnancy
* Alcool abuse
* Acute infection, past neurological or pancreatic disease, biological abnormalities
* Chemotherapy or immunotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Triangle Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Dupont Applied Biosciences

INDUSTRY

Sponsor Role collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Jean-Michel Molina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France

Genevieve Chene, MD, PhD

Role: STUDY_DIRECTOR

INSERM unité 593, Bordeaux, France

References

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Molina JM, Ferchal F, Rancinan C, Raffi F, Rozenbaum W, Sereni D, Morlat P, Journot V, Decazes JM, Chene G. Once-daily combination therapy with emtricitabine, didanosine, and efavirenz in human immunodeficiency virus-infected patients. J Infect Dis. 2000 Aug;182(2):599-602. doi: 10.1086/315711. Epub 2000 Jul 13.

Reference Type RESULT
PMID: 10915095 (View on PubMed)

Molina JM, Peytavin G, Perusat S, Lascoux-Combes C, Sereni D, Rozenbaum W, Chene G. Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial). HIV Med. 2004 Mar;5(2):99-104. doi: 10.1111/j.1468-1293.2004.00194.x.

Reference Type RESULT
PMID: 15012649 (View on PubMed)

Other Identifiers

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ANRS 091 MONTANA

Identifier Type: -

Identifier Source: org_study_id