HIV InfectionsPhase 2NCT00196625
Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-infected Patients in Virological Failure.
A Phase 2 study testing Amprenavir (drug), ABT-378/r (drug) and Ritonavir (drug) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Amprenavir (drug), ABT-378/r (drug) and Ritonavir (drug)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2000to Feb 2002
- Phase
- Phase 2
- 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
- Documented HIV infection
- CD4 cell count below 300/mm3
- Plasma HIV RNA over 30,000 copies/ml
- Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)
- Written informed consent
Who cannot join
- Biological abnormalities
- Pregnancy
- Alcool abuse
- History of pancreatitis, hepatic failure
- Acute HIV related infection
- Chemotherapy
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine
Paris
About this study
Official title: Study on Safety and Efficacy of Salvage Therapy With Amprenavir, Lopinavir and Ritonavir 200 mg/d or 400 mg/d in HIV-infected Patients in Virological Failure.ANRS 104 PUZZLE 1
HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.
Read the detailed description
HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors (NRTI), over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed. 100 patients with CD4 cell count below 300/mm3 and plasma HIV RNA over 30,000 copies/ml are to be included in four groups: amprenavir, lopinavir, NRTI, with ritonavir 200 mg.d or not (patients previously treated by additional ritonavir 200 or 400 mg/d).
- Conditions
- HIV Infections
- Being tested
- Amprenavir (drug), ABT-378/r (drug), Ritonavir (drug)
- Keywords
- HIV infections, Salvage therapy, Amprenavir, Lopinavir, Ritonavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amprenavir (drug)Drug
ABT-378/r (drug)Drug
Ritonavir (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of VIH RNA between week 0 and week 26
Secondary outcomes (5)
Disease progression
CD4 cell count
Safety
Pharmacokinetics
Genotypic resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2000
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gilles Raguin, MD, Principal investigator, Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine, Paris, FranceGenevieve Chene, MD, PhD, Study director, INSERM U593, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196625
- Sponsor's protocol ID
- ANRS 104 PUZZLE1
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2005
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raguin G, Chene G, Morand-Joubert L, Taburet AM, Droz C, Le Tiec C, Clavel F, Girard PM; Puzzle 1 Study Group. Salvage therapy with amprenavir, lopinavir and ritonavir 200 mg/d or 400 mg/d in HIV-infected patients in virological failure. Antivir Ther. 2004 Aug;9(4):615-25.
PubMed 15456093Taburet AM, Raguin G, Le Tiec C, Droz C, Barrail A, Vincent I, Morand-Joubert L, Chene G, Clavel F, Girard PM. Interactions between amprenavir and the lopinavir-ritonavir combination in heavily pretreated patients infected with human immunodeficiency virus. Clin Pharmacol Ther. 2004 Apr;75(4):310-23. doi: 10.1016/j.clpt.2003.12.013.
PubMed 15060509
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Safety and Efficacy of Salvage Therapy With Amprenavir, Lopinavir and Ritonavir 200 mg/d or 400 mg/d in HIV-infected Patients in Virological Failure.ANRS 104 PUZZLE 1
- ClinicalTrials.gov ID
- NCT00196625
- Acronym / sponsor ID
- ANRS 104 PUZZLE1
- Conditions
- HIV Infections
- Keywords
- HIV infections, Salvage therapy, Amprenavir, Lopinavir, Ritonavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Nov 2000
- Study completion
- Feb 2002
- First posted
- 20 Sep 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.
HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.
Detailed description
HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors (NRTI), over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed. 100 patients with CD4 cell count below 300/mm3 and plasma HIV RNA over 30,000 copies/ml are to be included in four groups: amprenavir, lopinavir, NRTI, with ritonavir 200 mg.d or not (patients previously treated by additional ritonavir 200 or 400 mg/d).
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)
- Documented HIV infection
- CD4 cell count below 300/mm3
- Plasma HIV RNA over 30,000 copies/ml
- Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)
- Written informed consent
Key exclusion criteria (6 listed)
- Biological abnormalities
- Pregnancy
- Alcool abuse
- History of pancreatitis, hepatic failure
- Acute HIV related infection
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 |
|---|---|---|
| Amprenavir (drug) | Drug | – |
| ABT-378/r (drug) | Drug | – |
| Ritonavir (drug) | Drug | – |
Primary outcome
Mean change of VIH RNA between week 0 and week 26
5 secondary outcomes
Disease progression
CD4 cell count
Safety
Pharmacokinetics
Genotypic resistance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 15456093Raguin G, Chene G, Morand-Joubert L, Taburet AM, Droz C, Le Tiec C, Clavel F, Girard PM; Puzzle 1 Study Group. Salvage therapy with amprenavir, lopinavir and ritonavir 200 mg/d or 400 mg/d in HIV-infected patients in virological failure. Antivir Ther. 2004 Aug;9(4):615-25.
- Results publication: PubMed 15060509Taburet AM, Raguin G, Le Tiec C, Droz C, Barrail A, Vincent I, Morand-Joubert L, Chene G, Clavel F, Girard PM. Interactions between amprenavir and the lopinavir-ritonavir combination in heavily pretreated patients infected with human immunodeficiency virus. Clin Pharmacol Ther. 2004 Apr;75(4):310-23. doi: 10.1016/j.clpt.2003.12.013.
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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.
Gilles Raguin, MD principal investigator
Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine, Paris, France
Genevieve Chene, MD, PhD study director
INSERM U593, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amprenavir (drug), ABT-378/r (drug) and Ritonavir (drug) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases 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 6 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: finished, as of the sponsor's last update on 15 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change of VIH RNA between week 0 and week 26. 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 NCT00196625, which also lists 2 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 Jun 2026.