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Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

This study is ongoing, but not recruiting participants.

Sponsored by: PPD
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00006397
  Purpose

The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Ritonavir
Drug: Stavudine
Drug: Didanosine
Phase III

MedlinePlus related topics:   AIDS    AIDS Medicines   

ChemIDplus related topics:   Indinavir    Indinavir Sulfate    Didanosine    Stavudine    Ritonavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Pharmacokinetics Study
Official Title:   A Study of the Combination of Indinavir, Ritonavir, Enteric-Coated ddI and d4T In Nucleoside and Non-Nucleoside Reverse Transcriptase Inhibitor Experienced Patients: An Open-Label Study Investigating Differences Between Women and Men

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   200
Study Start Date:   August 2000

Detailed Description:

Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have viral load (amount of HIV in the blood) greater than 500 copies/ml.
  • Have received anti-HIV treatment previously with an NNRTI plus an NRTI combination or only NRTIs for greater than 8 weeks and, if not currently on treatment, have been off treatment for 12 weeks or less.
  • Failed to keep their viral load low during previous anti-HIV treatment.
  • Are at least 18 years of age.
  • Agree to use an effective barrier method of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have used a protease inhibitor for more than 14 days.
  • Have used ddI or d4T for more than 30 days.
  • Are pregnant or breast-feeding.
  • Have an opportunistic (AIDS-related) infection requiring treatment at the time of enrollment.
  • Have, or appear to have, peripheral neuropathy (a painful condition affecting the nervous system) at the time of screening.
  • Are at risk for, or have had, pancreatitis (disease of the pancreas).
  • Have difficulty absorbing medications.
  • Have a cancer, other than Kaposi's sarcoma, that may require systemic treatment.
  • Have any medical condition or treatment that may cause a rise in viral load.
  • Have any other condition or previous treatment that would interfere with the study.
  • Are unable to take drugs by mouth.
  • Are receiving or have received recently any of the following drugs: terfenadine, astemizole, cisapride, triazolam, midazolam, ergot alkaloids, amiodarone, bepridil, flecainide, propafenone, quinidine, pimozide, rifampin, and intravenous (IV) pentamidine.
  • Are receiving vincristine, thalidomide, foscarnet, or cisplatin or other medications that may cause nerve damage.
  • Have received any experimental drug within 30 days prior to treatment.
  • Are receiving treatment with testosterone, anabolic steroids, growth hormone, or megestrol acetate, except for certain hormonal problems.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006397

Locations
United States, California
UCLA CARE Ctr    
      Los Angeles, California, United States, 90095
Univ of Southern California    
      Los Angeles, California, United States, 90033
East Bay AIDS Ctr    
      Berkeley, California, United States, 94705
United States, Florida
Saint Josephs Comprehensive Research Institute    
      Tampa, Florida, United States, 33607
North Broward Hosp District / HIV Clinical Research    
      Fort Lauderdale, Florida, United States, 33311
United States, Louisiana
Louisiana State Univ Med Ctr / HIV Outpatient Clinic    
      New Orleans, Louisiana, United States, 70112
United States, Massachusetts
JSI Research and Training Institute    
      Boston, Massachusetts, United States, 02210
United States, New Jersey
Univ of Med & Dentistry of New Jersey    
      Newark, New Jersey, United States, 07103
United States, New York
Univ of Rochester Med Ctr    
      Rochester, New York, United States, 14642
Harlem Hosp Ctr    
      New York, New York, United States, 10037
Beth Israel Med Ctr    
      New York, New York, United States, 10003
United States, Tennessee
Vanderbilt Univ School of Medicine    
      Nashville, Tennessee, United States, 37212
United States, Texas
Univ of Texas Southwestern Med Ctr    
      Dallas, Texas, United States, 75390
Puerto Rico
Ponce Univ Hosp    
      Ponce, Puerto Rico, 00731
Univ of Puerto Rico School of Med    
      Rio Piedras, Puerto Rico, 00935

Sponsors and Collaborators
PPD
  More Information


Study ID Numbers:   312A, BMS 2000
First Received:   October 10, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00006397
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Didanosine  
Drug Therapy, Combination  
Stavudine  
HIV Protease Inhibitors  
Sex Factors  
Ritonavir
Indinavir
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Didanosine
Indinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 10, 2008




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