NCT00006397

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: PPD Development, LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Indinavir sulfate
DRUG	Ritonavir
DRUG	Stavudine
DRUG	Didanosine

Timeline

• Start date: 2000-08-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

15 sites across 2 countries: United States, Puerto Rico