Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Ritonavir (Drug); Stavudine (Drug); Didanosine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: PPD
Summary
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.
Clinical Details
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
Study design: Treatment, Open Label, Pharmacokinetics Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Ponce Univ Hosp, Ponce 00731, Puerto Rico
Univ of Puerto Rico School of Med, Rio Piedras 00935, Puerto Rico
UCLA CARE Ctr, Los Angeles, California 90095, United States
Univ of Southern California, Los Angeles, California 90033, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Saint Josephs Comprehensive Research Institute, Tampa, Florida 33607, United States
North Broward Hosp District / HIV Clinical Research, Fort Lauderdale, Florida 33311, United States
Louisiana State Univ Med Ctr / HIV Outpatient Clinic, New Orleans, Louisiana 70112, United States
JSI Research and Training Institute, Boston, Massachusetts 02210, United States
Univ of Med & Dentistry of New Jersey, Newark, New Jersey 07103, United States
Univ of Rochester Med Ctr, Rochester, New York 14642, United States
Harlem Hosp Ctr, New York, New York 10037, United States
Beth Israel Med Ctr, New York, New York 10003, United States
Vanderbilt Univ School of Medicine, Nashville, Tennessee 37212, United States
Univ of Texas Southwestern Med Ctr, Dallas, Texas 75390, United States
Additional Information
Starting date: August 2000
Last updated: June 23, 2005
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