HIV InfectionsPhase 4NCT00122668
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients
A Phase 4 study testing non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors and protease inhibitor in people with HIV Infections and HIV-Associated Lipodystrophy Syndrome, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV-Associated Lipodystrophy Syndrome
- What is being tested?
- non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors and protease inhibitor
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2003to Jul 2005
- Phase
- Phase 4
- 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
- Confirmed HIV-1-infected diagnosis
- Naive of antiretroviral treatment
- Plasma viral load (VL) over 5000 copies/ ml
- CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
- Written, informed consent after approval by the local human research ethics committee
Who cannot join
- Acute opportunistic infection
- Pregnancy or breast feeding
- Cytotoxic systemic chemotherapy except for Kaposi sarcoma
- Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
- Polynuclear neutrophils below 750/mm3
- Hemoglobin below 8 g/dl
Show all 9Show fewer
- Platelets below 20 000/mm3
- Creatinine level over 1.5 (upper normal) UN
- ASAT, ALAT, bilirubin level over 3 UN
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere
Paris, 75013
About this study
Official title: Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121)
The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).
Read the detailed description
The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.
Patients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.
Lipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.
- Being tested
- non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, protease inhibitor
- Keywords
- HIV Protease Inhibitors, HIV-Associated Lipodystrophy Syndrome, HIV infections
- Medical subject headings
- HIV Infections, HIV-Associated Lipodystrophy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-nucleoside reverse transcriptase inhibitorsDrug
nucleoside reverse transcriptase inhibitorsDrug
protease inhibitorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
Secondary outcomes (12)
During the study until 96 weeks
Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml
Evolution of viral load
Evolution of CD4 lymphocytes
Evaluation of clinical safety
Evaluation of lipohypertrophic syndrome
Evaluation of glucidic and lipids metabolic profile
Evaluation of mitochondrial toxicity
Evaluation of bone toxicity by measurement of bone density
Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors
Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors
Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startNov 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Investigators
- Claudine Duvivier, MD, Principal investigator, Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, ParisDominique Costagliola, Study chair, INSERM U 720
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122668
- Sponsor's protocol ID
- ANRS121 HIPPOCAMPE
- Status last verified
- Nov 2005
- First submitted
- 21 Jul 2005
- Last updated
- 15 Nov 2005
- Results posted
- No
Publications
Soulie C, Assoumou L, Ghosn J, Duvivier C, Peytavin G, Ait-Arkoub Z, Molina JM, Costagliola D, Katlama C, Calvez V, Marcelin AG. Nucleoside reverse transcriptase inhibitor-sparing regimen (nonnucleoside reverse transcriptase inhibitor + protease inhibitor) was more likely associated with resistance comparing to nonnucleoside reverse transcriptase inhibitor or protease inhibitor + nucleoside reverse transcriptase inhibitor in the randomized ANRS 121 trial. AIDS. 2009 Jul 31;23(12):1605-8. doi: 10.1097/QAD.0b013e32832d9031.
PubMed 19487903Duvivier C, Kolta S, Assoumou L, Ghosn J, Rozenberg S, Murphy RL, Katlama C, Costagliola D; ANRS 121 Hippocampe study group. Greater decrease in bone mineral density with protease inhibitor regimens compared with nonnucleoside reverse transcriptase inhibitor regimens in HIV-1 infected naive patients. AIDS. 2009 Apr 27;23(7):817-24. doi: 10.1097/QAD.0b013e328328f789.
PubMed 19363330Duvivier C, Ghosn J, Assoumou L, Soulie C, Peytavin G, Calvez V, Genin MA, Molina JM, Bouchaud O, Katlama C, Costagliola D; ANRS 121 study group. Initial therapy with nucleoside reverse transcriptase inhibitor-containing regimens is more effective than with regimens that spare them with no difference in short-term fat distribution: Hippocampe-ANRS 121 Trial. J Antimicrob Chemother. 2008 Oct;62(4):797-808. doi: 10.1093/jac/dkn278. Epub 2008 Jul 18.
PubMed 18641035
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121)
- ClinicalTrials.gov ID
- NCT00122668
- Acronym / sponsor ID
- ANRS121 HIPPOCAMPE
- Keywords
- HIV Protease Inhibitors, HIV-Associated Lipodystrophy Syndrome, HIV infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 112 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Nov 2003
- Study completion
- Jul 2005
- First posted
- 22 Jul 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.
The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).
Detailed description
The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.
Patients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.
Lipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (5 listed)
- Confirmed HIV-1-infected diagnosis
- Naive of antiretroviral treatment
- Plasma viral load (VL) over 5000 copies/ ml
- CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
- Written, informed consent after approval by the local human research ethics committee
Key exclusion criteria (9 listed)
- Acute opportunistic infection
- Pregnancy or breast feeding
- Cytotoxic systemic chemotherapy except for Kaposi sarcoma
- Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
- Polynuclear neutrophils below 750/mm3
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 |
|---|---|---|
| non-nucleoside reverse transcriptase inhibitors | Drug | – |
| nucleoside reverse transcriptase inhibitors | Drug | – |
| protease inhibitor | Drug | – |
Primary outcome
Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
12 secondary outcomes
During the study until 96 weeks
Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml
Evolution of viral load
Evolution of CD4 lymphocytes
Evaluation of clinical safety
Evaluation of lipohypertrophic syndrome
Evaluation of glucidic and lipids metabolic profile
Evaluation of mitochondrial toxicity
Evaluation of bone toxicity by measurement of bone density
Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors
Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors
Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2005.
- Derived from this study: PubMed 19487903Soulie C, Assoumou L, Ghosn J, Duvivier C, Peytavin G, Ait-Arkoub Z, Molina JM, Costagliola D, Katlama C, Calvez V, Marcelin AG. Nucleoside reverse transcriptase inhibitor-sparing regimen (nonnucleoside reverse transcriptase inhibitor + protease inhibitor) was more likely associated with resistance comparing to nonnucleoside reverse transcriptase inhibitor or protease inhibitor + nucleoside reverse transcriptase inhibitor in the randomized ANRS 121 trial. AIDS. 2009 Jul 31;23(12):1605-8. doi: 10.1097/QAD.0b013e32832d9031.
- Derived from this study: PubMed 19363330Duvivier C, Kolta S, Assoumou L, Ghosn J, Rozenberg S, Murphy RL, Katlama C, Costagliola D; ANRS 121 Hippocampe study group. Greater decrease in bone mineral density with protease inhibitor regimens compared with nonnucleoside reverse transcriptase inhibitor regimens in HIV-1 infected naive patients. AIDS. 2009 Apr 27;23(7):817-24. doi: 10.1097/QAD.0b013e328328f789.
- Derived from this study: PubMed 18641035Duvivier C, Ghosn J, Assoumou L, Soulie C, Peytavin G, Calvez V, Genin MA, Molina JM, Bouchaud O, Katlama C, Costagliola D; ANRS 121 study group. Initial therapy with nucleoside reverse transcriptase inhibitor-containing regimens is more effective than with regimens that spare them with no difference in short-term fat distribution: Hippocampe-ANRS 121 Trial. J Antimicrob Chemother. 2008 Oct;62(4):797-808. doi: 10.1093/jac/dkn278. Epub 2008 Jul 18.
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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.
Claudine Duvivier, MD principal investigator
Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris
Dominique Costagliola study chair
INSERM U 720
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors and protease inhibitor in people with HIV Infections and HIV-Associated Lipodystrophy Syndrome, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 15 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96. 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 NCT00122668, which also lists 3 linked publications.
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 15 Nov 2005.