Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
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ClinicalTrials.gov Identifier: NCT00196599 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: September 20, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Antiretroviral Naive | Drug: emtricitabine, FTC (drug) Drug: didanosine, ddI (drug) Drug: efavirenz (drug) | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 39 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA |
Study Start Date : | February 1999 |
Study Completion Date : | September 2004 |

- Virological success
- Treatment adherence
- CD4 cell count
- Safety
- Progression of HIV infection
- Pharmacokinetics criteria

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196599
Principal Investigator: | Jean-Michel Molina, MD, PhD | Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France | |
Study Director: | Genevieve Chene, MD, PhD | INSERM unité 593, Bordeaux, France |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00196599 History of Changes |
Other Study ID Numbers: |
ANRS 091 MONTANA |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 20, 2005 |
Last Verified: | September 2005 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections Reverse Transcriptase Inhibitors |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Emtricitabine Efavirenz Didanosine Antiviral Agents Anti-Infective Agents |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites |