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
2 other identifiers
interventional
200
2 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
October 10, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 2001
October 10, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Univ of Southern California
Los Angeles, California, 90033, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311, United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607, 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
Beth Israel Med Ctr
New York, New York, 10003, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Vanderbilt Univ School of Medicine
Nashville, Tennessee, 37212, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390, United States
Ponce Univ Hosp
Ponce, 00731, Puerto Rico
Univ of Puerto Rico School of Med
Rio Piedras, 00935, Puerto Rico