Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV

NCT00027339 | Completed Phase 2

• 4 other identifiers: A512610079ACTG A5126AACTG A5126
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 14

Brief Summary

Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options, selecting an effective anti-HIV drug combination is difficult. A combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy, may decrease viral load and increase drug activity. Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient. This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patient's response to anti-HIV therapy.

Conditions

HIV Infections

Keywords

HIV-1; HIV Protease Inhibitors; RNA, Viral; Phenotype; Viral Load; Pharmacokinetics; Treatment Experienced

Interventions

lopinavir/ritonavir DRUG

indinavir sulfate DRUG

tenofovir disoproxil fumarate DRUG

ritonavir DRUG

fosamprenavir DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• Viral load greater than 2500 copies/ml within 60 days of study entry
• On regimen with at least one PI for a total of at least 48 weeks
• On the same PI regimen for at least 90 days prior to study entry
• Decreased susceptibility to two of these three PIs: LPV, APV, and IDV (documented by phenotype within 90 days prior to study entry)
• Have taken a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks anytime in previous treatment history, or have decreased susceptibility to at least two NNRTIs
• Have taken two or more nucleoside reverse transcriptase inhibitors (NRTIs) for at least 12 weeks anytime in previous treatment history
• Agrees to use acceptable methods of contraception
• Weighs 88 lbs or more

You may not qualify if:

• Cannot tolerate RTV, APV, FPV, LPV/RTV, or IDV
• Use of HIV vaccines, investigational agents, hydroxyurea, or therapy to affect the immune system within 60 days of study entry
• Serious kidney problems
• Pregnancy or breastfeeding
• Alcohol or drug use that would interfere with the study
• Serious illness that requires treatment or hospitalization (patients stable on therapy or who have finished therapy at least 14 days before study entry may be eligible)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (14)

USC CRS

Los Angeles, California, United States

Location

Stanford CRS

Palo Alto, California, 94305-5107, United States

Location

UC Davis Medical Center

Sacramento, California, 95814, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, United States

Location

Indiana Univ. School of Medicine, Wishard Memorial

Indianapolis, Indiana, 46202, United States

Location

Methodist Hosp. of Indiana

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, 27710, United States

Location

Vanderbilt Therapeutics CRS

Nashville, Tennessee, 37203, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00936-5067, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavir; Indinavir; Tenofovir; Ritonavir; fosamprenavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Douglas Richman, MD

  University of California, San Diego

  STUDY CHAIR

• Joseph J. Eron, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2001
• First Posted: December 5, 2001
• Study Completion: June 1, 2005
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

PR (1); US (13)