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OpenTrials
Completed

NCT Number: NCT00647244

Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients

To evaluate the efficacy and safety of switching from Retrovir to Tenofovir or Abacavir in HIV-infected patients

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital

Århus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-infection with undetectable viral load
  • Antiretroviral treatment including Retrovir for more than three months
  • If fertile female: Negative pregnancy test and use of safe contraception
  • Negative HBs-antigen titer

Exclusion criteria

  • Prior treatment with abacavir or tenofovir
  • Resistance towards abacavir or tenofovir
  • Tissue type HLA-B5701
  • Renal disease
  • Diabetes Mellitus
  • Osteoporosis
  • Pregnant or lactating subjects
  • Intravenous drug abuse
  • Hypersensitivity towards drugs or active ingredient used
  • ALAT > 5 times upper normal level
  • Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance

Treatment and study plan

Tenofovir disoproxil fumarate

Drug

Tenofovir disoproxil 245 mg oral tablet once daily

Abacavir

Drug

Abacavir 300 mg oral tablet twice daily

Primary outcomes

  1. Renal function measured by Cystatin-C and creatinine clearance

    Time frame: Weeks 0, 4, 8, 12, 24, 24, 48, 96

  2. Levels of renal tubule function markers in blood and urine

    Time frame: Weeks 0, 12, 24, 48, 96

  3. Bone mass assessed by DEXA

    Time frame: Weeks 0, 24, 48, 96

  4. Levels of bone turnover markers in blood and urine

    Time frame: Weeks 0, 12, 24, 48, 96

  5. Insulin resistance

    Time frame: Weeks 0, 12, 24, 48, 96

  6. Changes in body composition assessed by patient questionnaire and standardized examination by physician

    Time frame: Weeks 0, 12, 24, 48, 96

  7. Changes in subcutaneous adipose tissue assessed by DEXA

    Time frame: Week 0, 24, 48, 96

Secondary outcomes

  1. Patients with viral load < 40 copies/ml

    Time frame: Weeks 0, 4, 8, 12, 24, 48, 96

  2. CD-4 cell count

    Time frame: Weeks 0, 4, 8, 12, 24, 48, 96

  3. Fasting triglycerides, HDL and LDL

    Time frame: Weeks 0, 12, 24, 48, 96

  4. Development of resistance mutations

    Time frame: Weeks 0, 12, 24, 48, 96

  5. Development of adverse events and serious adverse events

    Time frame: Weeks 0, 4, 8, 12, 24, 48, 96

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Efficacy and Safety of Switching From AZT to Tenofovir

Acronym: SWAP

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 31, 2008
Registry last updated
Dec 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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