Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144170
First received: September 2, 2005
Last updated: June 23, 2014
Last verified: April 2014
  Purpose

The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.


Condition Intervention Phase
HIV Infections
Drug: Tipranavir (with low dose ritonavir)
Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Treatment Response at Week 48 [ Time Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.


Secondary Outcome Measures:
  • Treatment Response at Week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 32 [ Time Frame: week 32 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 40 [ Time Frame: week 40 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 56 [ Time Frame: week 56 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 64 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 72 [ Time Frame: week 72 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 80 [ Time Frame: week 80 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 88 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Treatment Response at Week 96 [ Time Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]
    Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Time to Treatment Failure Through 96 Weeks of Treatment [ Time Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]
    Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.

  • Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.

  • Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [ Time Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]
    Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.

  • Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 32 [ Time Frame: week 32 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 40 [ Time Frame: week 40 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 56 [ Time Frame: week 56 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 64 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Virologic Response at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1

  • Median Change From Baseline in Viral Load (Week 2) [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 4) [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 8) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 16) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 24) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 32) [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 40) [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 48) [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 56) [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 64) [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 72) [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 80) [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 88) [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load (Week 96) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Virologic Response at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 88 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response at Week 96 [ Time Frame: week 96 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<400 copies/mL

  • Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Viral Load < 50 copies/mL

  • Virologic Response at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Virologic Response at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Virologic response defined as Viral Load<50 copies/mL

  • Mean Change From Baseline in CD4+ Cell Count (Week 2) [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 4) [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 8) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 16) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 24) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 32) [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 40) [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 48) [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 56) [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 64) [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 72) [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 80) [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 88) [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4+ Cell Count (Week 96) [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. [ Time Frame: up to 75 weeks of treatment ] [ Designated as safety issue: No ]

    Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.

    The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.



Enrollment: 882
Study Start Date: February 2003
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tipranavir(TPV)/low dose ritonavir(r) Drug: Tipranavir (with low dose ritonavir)
Comparator protease inhibitor(CPI)/low dose ritonavir(r) Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to trial participation.
  2. Human immunodeficiency virus-1 infected males or females >=18 years of age.
  3. Screening genotypic resistance report indicating both of the following:

    • at least one primary protease mutation at the following sites 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M , and
    • no more than two protease mutations on codons 33, 82, 84, or 90.
  4. At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,

    • with at least 2 Protease inhibitor-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and
    • current Protease inhibitor-based antiretroviral medication regimen for at least 3 months prior to randomisation.
  5. Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening.
  6. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:

    • Total cholesterol <=400 mg/dl or 10,36 mm/L.
    • Total triglycerides <=750 mg/dl or 8,5 mm/L.
    • Alanine aminotransferase <=3x upper limit of normal and aspartate aminotransferase <=2.5x upper limit of normal.
    • Any Grade gamma-glutamyl transpeptidase is acceptable.
    • Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
    • All other laboratory test values <= Grade 1(Division of Acquired immune deficiency syndrome, National Institute of Health grading scale).
  7. Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.
  8. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
  9. A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).

Exclusion Criteria:

  1. Antiretroviral medication naïve.
  2. Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months.
  3. Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit.
  4. Female patients of child-bearing potential who:

    • have a positive serum pregnancy test at screening or during the study,
    • are breast feeding
    • are planning to become pregnant, or
    • are not willing to use a barrier method of contraception, or
    • require ethinyl estradiol administration
  5. Prior tipranavir use.
  6. Use of investigational medications within 30 days before study entry or during the trial. (T-20 [enfuvirtide] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)
  7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
  8. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
  9. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144170

  Show 174 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144170     History of Changes
Other Study ID Numbers: 1182.48, RESIST 2
Study First Received: September 2, 2005
Results First Received: September 11, 2009
Last Updated: June 23, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Bundesministerium fuer soziale Sicherheit und Generationen
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: Comitato Etico della Fondazione Centro San Raffaele del Monte Tabor - Milano
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Portugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 Lisboa
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Ritonavir
HIV Protease Inhibitors
Tipranavir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014