Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)

NCT00573001 | Completed Phase 3 DMC

• 2 other identifiers: ANRS12115 DAYANAIMEA 032
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.

Conditions

HIV Infections

Keywords

naive; HIV-1; simplified treatment; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with viral load below 50 copies/mL

  week 16

Secondary Outcomes (5)

• Percentage of patients with viral Load under 50 copies/ml and under 400 copies/ml

  W4, W12, W24, W36, W72, and W96

• Severe adverse event onset, metabolic alterations, lipodystrophia

  J0, W16, W24, W48, W72, W96

• Residual ARV plasmatic concentration

  W4, W48

• CD4 count evolution

  J0, W4, W16, W24, W36, W48, W72, W96

• quality of life parameters, observance

  J0, W4, W8, W12, W16, W24, W36, W48, W72, W96

Study Arms (4)

1

EXPERIMENTAL

Drug: Tenofovir/Emtricitabine (Truvada) and Nevirapine

2

EXPERIMENTAL

Drug: Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)

3

EXPERIMENTAL

Drug: Tenofovir/Emtricitabine (Truvada) and Zidovudine

4

ACTIVE COMPARATOR

Drug: Tenofovir/Emtricitabine/Efavirenz (Atripla)

Interventions

Tenofovir/Emtricitabine (Truvada) and Nevirapine DRUG

Tenofovir/Emtricitabine(Truvada) 245/200mg 1cp/day ; Nevirapine 200mg 2cp/day after first 14 days

Also known as: Truvada

1

Tenofovir/Emtricitabine/Efavirenz (Atripla) DRUG

Tenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day

Also known as: Atripla

4

Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia) DRUG

Tenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day

Also known as: Viread, Aluvia

2

Tenofovir/Emtricitabine (Truvada) and Zidovudine DRUG

Tenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day

Also known as: Truvada

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years for Senegal and over 21 years for Cameroon
• HIV-1 infected patient
• patient naive from any antiretroviral treatment
• CD4 cell count over 50 cells per mm3
• contraceptive method use
• informed consent signed

You may not qualify if:

• opportunistic infection ongoing or any other serious pathology
• ongoing treatment with rifampicine
• severe renal or hepatic impairment
• HbSAg positive
• Hemoglobine under 8g/L
• Neutrophils under 500 cells per mm3
• ongoing pregnancy or breastfeeding
• treatment by contra-indicated drugs (as described in study drugs notices)

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: collaborator
• Gilead Sciences: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Hopital Central

Yaoundé, Cameroon

Location

Hopital de Fann

Dakar, Senegal

Location

Related Links

• Sponsor web page

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Nevirapine; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir; Ritonavir; lopinavir-ritonavir drug combination; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Pyridines; Oxazines; Pyrimidinones; Thiazoles; Sulfur Compounds; Azoles; Thymidine; Dideoxynucleosides

Study Officials

• Landman Roland, MD

  Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

  PRINCIPAL INVESTIGATOR

• Sow Papa Salif, MD

  Hopital de Fann, Dakar

  PRINCIPAL INVESTIGATOR

• Koulla Shiro Sinata, MD

  Hopital Central Yaoundé

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

CA (1); SE (1)