Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

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Brief Title

Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

Official Title

Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities

Brief Summary

      The purpose of this study is to learn whether changing from a type of anti-HIV drug called a
      protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of
      fats or sugars in the blood.

      PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However,
      some people who take PIs have higher than normal levels of fats and/or sugars in the blood.
      Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the
      abnormal side effects. This study will test 3 different combinations of non-PI drugs to see
      which may improve side effects while keeping viral loads low.
    

Detailed Description

      Protease inhibitor (PI)-containing antiretroviral regimens are potent suppressors of HIV
      replication. Increasingly, metabolic abnormalities such as hypercholesterolemia and
      triglyceridemia are associated with PI use, reasons cited for switching to PI-sparing
      regimens. Yet optimal switch regimens that take into account both improvements in side
      effects and continued virologic suppression have not been defined. This study will compare
      the effect on chemical metabolic abnormalities of switching to an all nucleoside regimen
      versus dual nucleoside plus nonnucleoside reverse transcriptase inhibitor (NNRTI) therapy.
      Determining the effects of each regimen on chemical metabolic abnormalities and maintenance
      of virologic suppression will define which of the switch strategies being studied improves
      metabolic abnormalities without compromising viral suppression.

      Patients are stratified on the basis of fasting non-HDL cholesterol and triglyceride levels
      and on ritonavir- or nonritonavir-containing pre-entry PI regimens. Patients are assigned
      randomly to add to their pre-entry regimen 1 of the following 3 treatments: Arm A - ABC; Arm
      B - NVP; or Arm C - EFV.

      Patients discontinue pre-entry PIs after Day 14. Patients are followed to determine the
      effect of the maintenance regimens on fasting non-high-density lipoprotein (HDL),
      cholesterol, and triglycerides at Week 24. Fasting total cholesterol, HDL cholesterol, direct
      low-density lipoprotein, and triglycerides are measured at Weeks 12, 24, and 48. Fasting
      glucose, insulin, C-peptide, apolipoproteins A-1 and B, lipoprotein a, and homocysteine are
      measured at Weeks 24 and 48. Anthropometrics, body mass index, and body image are measured at
      Weeks 12, 24, and 48. HIV viral load is measured at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40,
      and 48. If HIV RNA stays below 200 copies/ml, therapy continues unchanged. If confirmed HIV
      RNA of 200 copies/ml or higher is found, an HIV genotype is obtained providing the viral load
      is sufficient to yield results, the best medical therapy is instituted (not supplied by the
      study), and off treatment/on study follow-up is continued. If patients are intolerant to a
      study drug, an alternate study drug (ABC, EFV, or NVP supplied by the study) is permitted and
      switched treatment/on study follow-up continued, or the best medical therapy is instituted
      (not supplied by the study), and off treatment/on study follow-up is continued. Patients are
      followed until the last patient enrolled has completed 48 weeks on study.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

HIV Infections

Intervention

Abacavir sulfate, Lamivudine and Zidovudine


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

342



Primary Completion Date

February 2002

Eligibility Criteria

        Inclusion Criteria

        Patients may be eligible for this study if they:

          -  Are HIV infected.

          -  Are on their first combination of stable anti-HIV drugs (have not changed drugs for at
             least 6 months, except for reasons other than failing treatment or short interruptions
             of less than 7 days).

          -  Have 2 measurements of viral load (amount of HIV in the blood) during the 6 months
             before entering the study that are below 400 copies/ml by RT-PCR test or below 500
             copies/ml by branched DNA test, measured at least 8 weeks apart.

          -  Have a viral load below 50 copies/ml within 30 days prior to entry.

          -  Have a CD4 cell count of 200 copies/ml or higher within 60 days of study entry.

          -  Are receiving medications and/or medications at certain doses that might interfere
             with the study.

          -  Are at least 13 years old and have signed consent of parent or guardian if under 18
             years of age.

          -  Have a negative pregnancy test within 14 days of study entry, if a woman able to have
             children.

          -  Agree to use a barrier method of birth control, men and women, while receiving study
             drugs and for 3 months afterwards.

        Exclusion Criteria

        Patients will not be eligible for this study if they:

          -  Are receiving high doses of testosterone. Low doses are allowed if received for 60 or
             more days before entering the study with no plans to change the dose during the first
             24 weeks of the study.

          -  Have had treatment with any nonnucleoside reverse transcriptase inhibitor (NNRTI).

          -  Have had treatment with ABC.

          -  Are allergic to study drugs or any ingredient in them.

          -  Are pregnant or breast-feeding.

          -  Have used any HIV vaccine or drugs affecting the immune system within 30 days prior to
             entering the study.

          -  Have had systemic treatment for cancer within 30 days of entering the study.

          -  Have had systemic treatment with certain other drugs that may interfere with the study
             within 14 days of entering the study.

          -  Have a serious illness that required systemic treatment or a hospital stay unless
             treatment was completed at least 14 days prior to entering the study, or are on stable
             treatment, in the doctor's opinion, for at least 14 days prior to entering the study.

          -  Abuse drugs or alcohol.

          -  Have or suspect they have acute hepatitis within 30 days of entering the study.
      

Gender

All

Ages

13 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David Wohl, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00021463

Organization ID

ACTG A5103

Secondary IDs

AACTG A5103


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

David Wohl, Study Chair, 


Verification Date

January 2003