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

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

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Indinavir sulfate; Drug: Stavudine; Drug: Ritonavir; Drug: Didanosine

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.

• Study Type: Interventional
• Enrollment: 200
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: PPD

Study record dates

Study Major Dates

• Study Start: August 1, 2000

Study Registration Dates

• First Submitted: October 10, 2000
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: June 1, 2001

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Stavudine; Didanosine; HIV Protease Inhibitors; Ritonavir; Indinavir; Sex Factors; Dosage Forms
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Stavudine; Indinavir; Didanosine
• Other Study ID Numbers: 312A; BMS 2000