NCT00023218

Brief Summary

The purpose of this study is to look at how 2 different anti-HIV drug treatments affect the liver. The use of anti-HIV drugs like the nucleoside reverse transcriptase inhibitors (NRTIs) may be linked to liver problems like fatty changes, scarring, abnormal liver function tests (LFTs), and lactic acidemia (an increase in lactic acid in the blood). Increased liver enzymes may mean liver damage. The way that the liver changes in people with abnormal LFTs and lactic acidemia is not completely understood.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

March 9, 2015

Status Verified

June 1, 2003

First QC Date

August 29, 2001

Last Update Submit

March 5, 2015

Conditions

HIV InfectionsHepatitis C

Keywords

LiverHIV-1HIV Protease InhibitorsRitonavirBiopsyReverse Transcriptase InhibitorsAnti-HIV AgentsABT 378Acidosis, LacticefavirenzAlanine Transaminase

Interventions

Lopinavir/RitonavirDRUG
EfavirenzDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Have a higher than normal level of lactic acid and liver enzymes in blood within 45 days prior to study entry.
  • Are HIV infected.
  • Have been receiving an anti-HIV drug combination containing an NRTI for more than 12 months continuously before entering the study.
  • Have an HIV viral load (amount of HIV in the blood) of less than 200 copies/ml within 70 days prior to study entry.
  • Have a negative pregnancy test within 45 days prior to study entry.
  • Agree to use 2 approved methods of birth control while participating in sexual activity that could lead to pregnancy, while receiving study medications and for 6 weeks after stopping the medications, both men and women and their partners, if able to have children.
  • Are at least 13 years of age.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have hepatitis B according to certain lab tests.
  • Have known causes for liver disease other than HCV or anti-HIV therapy.
  • Regularly and excessively use alcohol.
  • Are unwilling to restrict alcohol use to the amount allowed during the study.
  • Have untreated endocrine disease such as diabetes and Cushing's disease. Diabetes that is under good control, stable hypothyroidism on replacement therapy, and stable hypogonadism on replacement therapy will be allowed.
  • Receive prednisone within 1 month of study entry or high levels of prednisone (greater than 10 mg/day) within 90 days of study entry.
  • Have had poorly controlled congestive heart failure within the last 12 months.
  • Have signs and symptoms of abnormal liver function.
  • Are unwilling to have a liver biopsy.
  • Have a swollen abdomen due to accumulated fluid.
  • Are suspected of having liver cancer.
  • Are pregnant and breast-feeding.
  • Abuse drugs.
  • Have a serious illness within 14 days prior to entry.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Tripler Army Med Ctr

Tripler AMC, Hawaii, 96859, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis CAcidosis, Lactic

Interventions

Lopinavirefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Cecilia Shikuma

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 29, 2001

First Posted

August 31, 2001

Last Updated

March 9, 2015

Record last verified: 2003-06

Locations

US(3)