Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00006397
- Lead Sponsor
- PPD
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
JSI Research and Training Institute
🇺🇸Boston, Massachusetts, United States
Univ of Texas Southwestern Med Ctr
🇺🇸Dallas, Texas, United States
Univ of Med & Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Saint Josephs Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
North Broward Hosp District / HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Univ of Puerto Rico School of Med
🇵🇷Rio Piedras, Puerto Rico
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
🇺🇸New Orleans, Louisiana, United States
Ponce Univ Hosp
🇵🇷Ponce, Puerto Rico
Univ of Southern California
🇺🇸Los Angeles, California, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Vanderbilt Univ School of Medicine
🇺🇸Nashville, Tennessee, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States