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PREventing Progression of Adipose Tissue Redistribution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00389194
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : June 11, 2010
Gilead Sciences
Information provided by:
International Antiviral Therapy Evaluation Center

Brief Summary:
The main objective of the study is to assess changes in fat distribution over 48 weeks of treatment in patients who currently successfully use zidovudine (AZT) and lamivudine (3TC) as part of their regimen and who will either continue these antiretrovirals or who will switch these antiretrovirals to tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Each of these medications is commonly used for the treatment of HIV-1 infection.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: continuing AZT+3TC or switching AZT+3TC to TDF+ FTC Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Open-Label, 48-Week Study of Continuing Successfully Suppressive Treatment in HIV-1 Infected Adults With First-Line Twice-Daily Zidovudine and Lamivudine-Based Regimens Versus Pro-actively Replacing of Zidovudine and Lamivudine by Once-Daily Emtricitabine and Tenofovir Disoproxil Fumarate to Prevent Progression of or Reverse Peripheral Lipoatrophy.
Study Start Date : April 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Secondary Outcome Measures :
  1. Difference between the continuation arm and the switch arm in:
  2. changes in subcutaneous and visceral abdominal fat by CT and truncal fat by whole body DEXA over 48 weeks
  3. changes in lipids (total-, HDL-, and LDL-cholesterol, total /HDL cholesterol ratio, triglycerides), and glucose-metabolism (glucose, insulin) and insulin resistance (HOMA-index1) over 48 weeks.
  4. incidence of new onset of lipodystrophy and changes in lipodystrophy severity according to the LDCD score.
  5. changes in bone mineral density by regional DEXA (vertebra L4 and femoral neck) over 48 weeks
  6. proportion of patients with plasma HIV-1 RNA concentrations < 50 copies/mL after 48 weeks and proportion of patients that developed new CDC-C events or increased in CDC classification.
  7. incidence and severity of adverse events (grade 3 and 4), and laboratory abnormalities (grade 1-4)
  8. A comparison between different GFR-estimations and the gold standard for GFR-measurement in HIV-1 infected patients on HAART. [ Time Frame: baseline ]
    Conclusions: Each eGFR estimation underestimated the mGFR. In patients with preserved renal function and suppressed HIV-infection, C&G, 24-hours urine clearance and MDRD-6 based eGFR reasonably estimated true GFR, but cysC-based eGFR did not.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Providing written informed consent
  • HIV-1 infected patients.
  • At least 18 years of age.
  • Males or non-pregnant, non-lactating females. Women of childbearing age must have a negative urine pregnancy test at screening. All female participants must be encouraged to utilise adequate contraception for the month preceding entry and for the duration of the study.
  • Treatment for at least two years with a first-line regimen of zidovudine plus lamivudine (as either a fixed dose combination or dosed separately) plus either an NNRTI or a (boosted) PI. Patients may have previously used multiple drugs from both the NNRTI or the PI classes.
  • Plasma HIV-1 RNA levels < 50 copies/mL for at least 6 months at screening. Isolated measurements of plasma HIV-1 RNA levels above 50 but below 200 copies/ml (socalled blips) are allowed.

Exclusion Criteria:

  • Prior treatment with an NRTI other than zidovudine or lamivudine.
  • Use of a triple NRTI antiretroviral regimen or a regimen including unboosted saquinavir, fusion inhibitors or hydroxyurea
  • Prior virological treatment failure, defined as having had to switch antiretroviral therapy because of virologic failure in the opinion of the physician.
  • HIV-2 co-infection.
  • Renal impairment and/or use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate.
  • Clinically relevant laboratory abnormalities: anemia, thrombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase.
  • Use of co-medication, other than antiretroviral drugs, with a known pharmacological interaction with one or more of the study drugs
  • Active alcohol or drug use, sufficient in the investigator's opinion to prevent compliance with the dosing schedule and evaluations (methadone and buprenorphine use is allowed, although the dose of methadone might need to be adjusted).
  • Anticipated non-compliance with the protocol.
  • Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study.
  • Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs.
  • Women who have the intention to become pregnant during the study period.
  • Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period.
  • Patients who have taken any investigational drug 30 days prior to the start of the study
  • Patients with malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or prevent the patient from taking oral medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00389194

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Academic Medical Centre
Amsterdam, Netherlands
Sponsors and Collaborators
International Antiviral Therapy Evaluation Center
Gilead Sciences
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Study Chair: Peter Reiss, MD, PhD Academic Medical Centre
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00389194    
Other Study ID Numbers: PR-0095_01
Eudract number: 2005-005672-33
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010
Keywords provided by International Antiviral Therapy Evaluation Center:
HIV-1 infection
fat distribution
kidney function
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases