Back to resultsDual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week
Primary Purpose
HIV Infections
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ARV bitherapie
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring bitherapy, treatment discontinution, 4 days per week
Eligibility Criteria
Inclusion Criteria:
- HIV-1 infection, coinfection HIV-1/HIV-2 possible
- Age≥18 years old
- Current dual therapy unchanged for the last 6 months with Dolutegravir/ Lamivudine or Dolutegravir / Rilpivirine or Darunavir/r / Lamivudine
- If a genotype is available in the patient medical history; virus must be susceptible to all on going dual therapy. If no ARN genotype available, the patients can be included in the study
- Viral load (VL) < 50 c/mL in the past twelve months, with at least 3 VL measurements including screening; only one blip < 200 c/mL is authorized in the 6-12 previous months
- CD4 T cells > 250/mm3 at W-4
- Estimated glomerular filtration rate > 60 mL/min (CKD-EPI method)
- AST et ALT < 3N
- Haemoglobin > 10 g/dL
- Platelets > 100 000/mm3
- For women of childbearing age, negative pregnancy plasmatic test at W-4 and agree to use efficacy contraception during the study
- Commitment to use condom prevention and protection during sexual intercourse for the duration of the trial.
- Social security system coverage (including State Medical Aid-AME, if EC approves it)
- Informed consent form signed
Exclusion Criteria:
- Infection by HIV-2
- Chronic and active Viral B Hepatitis with positive antigen HBs
- Chronic and active Viral C Hepatitis with treatment expected in the next 48 weeks
- Concomitant treatment using interferon, interleukins, any other immune-therapy or chemotherapy, antivitamin K+ with co-treatment by booster
- Concomitant prophylactic or curative treatment for an opportunistic infection
- All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with study protocol compliance, observance and/or study treatment tolerance
- Pregnant or breast feeding women
- Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
Sites / Locations
- Hôpital Louis Pasteur/Service des Maladies InfectieusesRecruiting
- Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'ImmunologieRecruiting
- Hôpital Avicenne/Service des Maladies Infectieuses et tropicalesRecruiting
- Hôpital Saint André/Service HDJ Maladies InfectieusesRecruiting
- Hôpital Pellegrin/Service des Maladies Infectieuses et TropicalesRecruiting
- Hôpital Côte de Nacre/Service des Maladies InfectieusesRecruiting
- Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine InterneRecruiting
- Centre Hospitalier Sud-Francilien/Service d'HématologieRecruiting
- Hôpital François Mitterrand/Service des Maladies InfectieusesRecruiting
- Hôpital Raymond Poincaré/Service des Maladies InfectieusesRecruiting
- CHD de La Roche sur Yon/Service de Médecine InterneRecruiting
- Hôpital Franco-Britannique-Fondation Cognacq-JayRecruiting
- CHU Dupuytren 1/Service des Maladies Infectieuses et TropicalesRecruiting
- Hôpital de la Croix Rousse/Service des Maladies InfectieusesRecruiting
- Hôpital Européen/Consultation de Médecine Interne et Maladies InfectieusesRecruiting
- Hôpital Sainte Marguerite/Service d'Immuno-Hématologie CliniqueRecruiting
- Hôpital Gui de Chauliac/Service des Maladies InfectieusesRecruiting
- Hôpital de l'Hôtel Dieu/Service des Maladies InfectieusesRecruiting
- Hôpital de l'Archet/Service des Maladies InfectieusesRecruiting
- Hôpital Lariboisière/Service de Médecine InterneRecruiting
- Hôpital Saint Louis/Service des Maladies InfectieusesRecruiting
- Hôpital Saint Antoine/Service des Maladies InfectieusesRecruiting
- Hôpital Pitié-Salpêtrière/Service des Maladies InfectieusesRecruiting
- Hôpital Necker/Service des Maladies InfectieusesRecruiting
- Hôpital Tenon/Service des Maladies InfectieusesRecruiting
- Hôpital Hôtel Dieu/Service d'Immunologie CliniqueRecruiting
- Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie InfectieuseRecruiting
- Hôpital Bichat/Service des Maladies InfectieusesRecruiting
- Centre hospitalier de Poissy/Service des Maladies InfectieusesRecruiting
- Centre Hospitalier René Dubos/Service de DermatologieRecruiting
- Hôpital Robert DEBRE/Service des maladies infectieuses
- Hôpital Delafontaine/Service des Maladies InfectieusesRecruiting
- Hôpital Civil/Service Le Trait D'union UF 2066Recruiting
- Hôpital Foch/Service de Médecine InterneRecruiting
- Hôpital Purpan/Service des Maladies InfectieusesRecruiting
- Hôpital Gustave Dron/Service des Maladies InfectieusesRecruiting
- Hôpital Bretonneau/Service des Maladies InfectieusesRecruiting
- Hôpital Pierre Zobda-Quitman/Service de Médecine InterneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1: 4 days/7
Arm 2: 7 days/7
Arm Description
4 days/7 Patients included in this arm will take their ARV treatment 4 consecutive days per week during 48 weeks.
Patients included in this arm will take their ARV treatment 7 days per week during 48 weeks
Outcomes
Primary Outcome Measures
Proportion of patients with virological failure at Week 48.
The virological failure is defined by 2 successive viral loads >50 c/mL at 2 to 4 weeks apart or a viral load > 50 c/ml with a definitive stop of the study follow-up or the study strategy
Secondary Outcome Measures
Proportion of participants with therapeutic success until Week 48
Percentage of participants with at least one episode of "blip"
viral load >50 copies/mL followed by a control value ≤ 50 cp/mL
Percentage of participants with a viral load signal detected
Evolution of ultrasensitive viral load and total DNA in the PBMC at W0 and W48
immuno-virological sub-study
Proportion of participants with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by NGS
Description of selected mutations at the virological failure
Frequency of minority resistant variants archived in DNA at W0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations
Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE)
Evolution of T CD4 and CD8 cells count, and CD4/CD8 ratio
Evolution of fasting metabolic parameters (total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia) until W0 and W48
Evolution of weight between Week 0 and Week 48
Evolution of inflammation serum parameters
immuno-virological sub-study- (sCD14, sCD163, IP-10, CRPus, IL-6, D-dimers, sTNFR1, sTNFR2) from W0 to W24 and W48
Evolution of semen viral load at Week 0, Week 24 and Week 48
Sub-study
Description and comparison of plasmatic concentrations of antiretroviral agents between the 2 groups at ON and OFF period
Evaluation of the adherence by self-reported questionnaire
Evolution of the quality of life by self-reported questionnaire
Full Information
NCT ID
NCT04867083
First Posted
April 20, 2021
Last Updated
November 5, 2021
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT04867083
Brief Title
Dual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week
Official Title
Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy.
Detailed Description
Open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non-inferiority of antiretroviral dual therapy taken 4 consecutive days a week versus dual therapy taken 7 days a week, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral dual therapy since 4 months. The non-inferiority margin (delta) is 5%. The randomization will be stratified according to the family of the dual therapy at the moment of the inclusion and according to the participation of the substudy or not.
The sample size calculation assumes that the true difference in efficacy between the two arms is zero and that the overall response rate is 97% at week 48. A total of 440 patients (220 per arm) is required to provide 80% power to demonstrate non-inferior efficacy for the 4/7 strategy, compared to the daily dual therapy (7/7), with a two-sided significance level of 5% and a non-inferiority margin (delta) of -5%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
bitherapy, treatment discontinution, 4 days per week
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label, multicenter, prospective, randomized trial in 2 parallel groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: 4 days/7
Arm Type
Experimental
Arm Description
4 days/7 Patients included in this arm will take their ARV treatment 4 consecutive days per week during 48 weeks.
Arm Title
Arm 2: 7 days/7
Arm Type
Active Comparator
Arm Description
Patients included in this arm will take their ARV treatment 7 days per week during 48 weeks
Intervention Type
Drug
Intervention Name(s)
ARV bitherapie
Intervention Description
Dolutégravir 50mg / Lamivudine 300mg per day
Dolutégravir 50mg / Rilpivirine 25mg per day
Darunavir/r 800mg/100mg / Lamivudine 300mg per day
Primary Outcome Measure Information:
Title
Proportion of patients with virological failure at Week 48.
Description
The virological failure is defined by 2 successive viral loads >50 c/mL at 2 to 4 weeks apart or a viral load > 50 c/ml with a definitive stop of the study follow-up or the study strategy
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Proportion of participants with therapeutic success until Week 48
Time Frame
Week 48
Title
Percentage of participants with at least one episode of "blip"
Description
viral load >50 copies/mL followed by a control value ≤ 50 cp/mL
Time Frame
Week 0 to Week48
Title
Percentage of participants with a viral load signal detected
Time Frame
Week 0 to Week 48
Title
Evolution of ultrasensitive viral load and total DNA in the PBMC at W0 and W48
Description
immuno-virological sub-study
Time Frame
Week 0 and Week 48
Title
Proportion of participants with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by NGS
Time Frame
Week 0 to Week 48
Title
Description of selected mutations at the virological failure
Time Frame
Week 0 to Week 48
Title
Frequency of minority resistant variants archived in DNA at W0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations
Time Frame
Week 0
Title
Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE)
Time Frame
Week 0 to Week 48
Title
Evolution of T CD4 and CD8 cells count, and CD4/CD8 ratio
Time Frame
Week-4 to Week 48
Title
Evolution of fasting metabolic parameters (total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia) until W0 and W48
Time Frame
Week 0 to Week 48
Title
Evolution of weight between Week 0 and Week 48
Time Frame
Week 0 and Week 48
Title
Evolution of inflammation serum parameters
Description
immuno-virological sub-study- (sCD14, sCD163, IP-10, CRPus, IL-6, D-dimers, sTNFR1, sTNFR2) from W0 to W24 and W48
Time Frame
Week 0 to Week 24 and Week 48
Title
Evolution of semen viral load at Week 0, Week 24 and Week 48
Description
Sub-study
Time Frame
Week 0-Week 24 and Week 48
Title
Description and comparison of plasmatic concentrations of antiretroviral agents between the 2 groups at ON and OFF period
Time Frame
Week 0-Week 8-Week 24-Week 48
Title
Evaluation of the adherence by self-reported questionnaire
Time Frame
At Week 0, Week 8, Week 24, Week 36 and Week 48-the evaluation will be done after analysis of all the points
Title
Evolution of the quality of life by self-reported questionnaire
Time Frame
Week-4 to Week 48-the evaluation will be done after analysis of all the points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 infection, coinfection HIV-1/HIV-2 possible
Age≥18 years old
Current dual therapy unchanged for the last 6 months with Dolutegravir/ Lamivudine or Dolutegravir / Rilpivirine or Darunavir/r / Lamivudine
If a genotype is available in the patient medical history; virus must be susceptible to all on going dual therapy. If no ARN genotype available, the patients can be included in the study
Viral load (VL) < 50 c/mL in the past twelve months, with at least 3 VL measurements including screening; only one blip < 200 c/mL is authorized in the 6-12 previous months
CD4 T cells > 250/mm3 at W-4
Estimated glomerular filtration rate > 60 mL/min (CKD-EPI method)
AST et ALT < 3N
Haemoglobin > 10 g/dL
Platelets > 100 000/mm3
For women of childbearing age, negative pregnancy plasmatic test at W-4 and agree to use efficacy contraception during the study
Commitment to use condom prevention and protection during sexual intercourse for the duration of the trial.
Social security system coverage (including State Medical Aid-AME, if EC approves it)
Informed consent form signed
Exclusion Criteria:
Infection by HIV-2
Chronic and active Viral B Hepatitis with positive antigen HBs
Chronic and active Viral C Hepatitis with treatment expected in the next 48 weeks
Concomitant treatment using interferon, interleukins, any other immune-therapy or chemotherapy, antivitamin K+ with co-treatment by booster
Concomitant prophylactic or curative treatment for an opportunistic infection
All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with study protocol compliance, observance and/or study treatment tolerance
Pregnant or breast feeding women
Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karine AMAT
Phone
0140256352
Ext
33
Email
karine.amat@imea.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aida BENALYCHERIF
Phone
0140256365
Ext
33
Email
aida.benalycherif@imea.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland LANDMAN
Organizational Affiliation
Hôpital BICHAT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Louis Pasteur/Service des Maladies Infectieuses
City
Chartres
State/Province
Le Coudray
ZIP/Postal Code
28630
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana DARASTEANU
Facility Name
Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie
City
Argenteuil Cedex
ZIP/Postal Code
95107
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne CABY
Facility Name
Hôpital Avicenne/Service des Maladies Infectieuses et tropicales
City
Bobigny cedex
ZIP/Postal Code
93009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BOUCHAUD
Facility Name
Hôpital Saint André/Service HDJ Maladies Infectieuses
City
Bordeaux cedex
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MORLAT
Facility Name
Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales
City
Bordeaux cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier NEAU
Facility Name
Hôpital Côte de Nacre/Service des Maladies Infectieuses
City
Caen cedex 9
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud VERDON
Facility Name
Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine Interne
City
Clamart cedex
ZIP/Postal Code
92141
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie ABGRALL
Facility Name
Centre Hospitalier Sud-Francilien/Service d'Hématologie
City
Corbeil-Essonnes cedex
ZIP/Postal Code
91106
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie CHABROL
Facility Name
Hôpital François Mitterrand/Service des Maladies Infectieuses
City
Dijon cedex
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel PIROTH
Facility Name
Hôpital Raymond Poincaré/Service des Maladies Infectieuses
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre DE TRUCHIS
Facility Name
CHD de La Roche sur Yon/Service de Médecine Interne
City
La Roche sur Yon cedex 9
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BOLLENGIER-STRAGIER
Facility Name
Hôpital Franco-Britannique-Fondation Cognacq-Jay
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles FORCE
Facility Name
CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire GENET
Facility Name
Hôpital de la Croix Rousse/Service des Maladies Infectieuses
City
Lyon cedex 4
ZIP/Postal Code
69317
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick MIAILHES
Facility Name
Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses
City
Marseille cedex 01
ZIP/Postal Code
13331
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina PSOMAS
Facility Name
Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique
City
Marseille cedex 9
ZIP/Postal Code
13274
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia ZAEGEL-FAUCHER
Facility Name
Hôpital Gui de Chauliac/Service des Maladies Infectieuses
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques REYNES
Facility Name
Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clothilde ALLAVENA
Facility Name
Hôpital de l'Archet/Service des Maladies Infectieuses
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa RIO
Facility Name
Hôpital Lariboisière/Service de Médecine Interne
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam DIEMER
Facility Name
Hôpital Saint Louis/Service des Maladies Infectieuses
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie DE CASTRO
Facility Name
Hôpital Saint Antoine/Service des Maladies Infectieuses
City
Paris cedex 12
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine LACOMBE
Facility Name
Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine KATLAMA
Facility Name
Hôpital Necker/Service des Maladies Infectieuses
City
Paris cedex 15
ZIP/Postal Code
75743
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudine DUVIVIER
Facility Name
Hôpital Tenon/Service des Maladies Infectieuses
City
Paris cedex 20
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles PIALOUX
Facility Name
Hôpital Hôtel Dieu/Service d'Immunologie Clinique
City
Paris cedex 4
ZIP/Postal Code
75181
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette PAVIE
Facility Name
Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse
City
Paris cedex 4
ZIP/Postal Code
75181
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique SALMON-CERON
Facility Name
Hôpital Bichat/Service des Maladies Infectieuses
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland LANDMAN
Facility Name
Centre hospitalier de Poissy/Service des Maladies Infectieuses
City
Poissy
ZIP/Postal Code
78300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit CAZENAVE
Facility Name
Centre Hospitalier René Dubos/Service de Dermatologie
City
Pontoise
ZIP/Postal Code
95301
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BLUM
Facility Name
Hôpital Robert DEBRE/Service des maladies infectieuses
City
Reims cedex
ZIP/Postal Code
51092
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firouzé BANI-SADR
Facility Name
Hôpital Delafontaine/Service des Maladies Infectieuses
City
Saint Denis cedex 1
ZIP/Postal Code
93205
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Aude KHUONG-JOSSES
Facility Name
Hôpital Civil/Service Le Trait D'union UF 2066
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David REY
Facility Name
Hôpital Foch/Service de Médecine Interne
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David ZUCMAN
Facility Name
Hôpital Purpan/Service des Maladies Infectieuses
City
Toulouse cedex
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre DELOBEL
Facility Name
Hôpital Gustave Dron/Service des Maladies Infectieuses
City
Tourcoing cedex
ZIP/Postal Code
59208
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier ROBINEAU
Facility Name
Hôpital Bretonneau/Service des Maladies Infectieuses
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis BERNARD
Facility Name
Hôpital Pierre Zobda-Quitman/Service de Médecine Interne
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André CABIE
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12545079
Citation
Fischer M, Hafner R, Schneider C, Trkola A, Joos B, Joller H, Hirschel B, Weber R, Gunthard HF; Swiss HIV Cohort Study. HIV RNA in plasma rebounds within days during structured treatment interruptions. AIDS. 2003 Jan 24;17(2):195-9. doi: 10.1097/00002030-200301240-00009.
Results Reference
background
PubMed Identifier
11394983
Citation
Vergis EN, Paterson DL, Wagener MM, Swindells S, Singh N. Dyslipidaemia in HIV-infected patients: association with adherence to potent antiretroviral therapy. Int J STD AIDS. 2001 Jul;12(7):463-8. doi: 10.1258/0956462011923507.
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Dual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week
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