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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00006397
First received: October 10, 2000
Last updated: June 23, 2005
Last verified: June 2001
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California
Los Angeles, California, United States, 90033
United States, Florida
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, United States, 33311
Saint Josephs Comprehensive Research Institute
Tampa, Florida, United States, 33607
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
Beth Israel Med Ctr
New York, New York, United States, 10003
Harlem Hosp Ctr
New York, New York, United States, 10037
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
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

No publications provided

ClinicalTrials.gov Identifier: NCT00006397     History of Changes
Other Study ID Numbers: 312A, BMS 2000
Study First Received: October 10, 2000
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Didanosine
Indinavir
Reverse Transcriptase Inhibitors
Ritonavir
Stavudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014