Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006397
• Other study ID #: 312A
• Secondary ID: BMS 2000
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 10, 2000
• Last updated: June 23, 2005
• Start date: August 2000

Study information

• Verified date: June 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Ritonavir

• Stavudine

• Didanosine

Locations

Country	Name	City	State
Puerto Rico	Ponce Univ Hosp	Ponce
Puerto Rico	Univ of Puerto Rico School of Med	Rio Piedras
United States	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	North Broward Hosp District / HIV Clinical Research	Fort Lauderdale	Florida
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Southern California	Los Angeles	California
United States	Vanderbilt Univ School of Medicine	Nashville	Tennessee
United States	Louisiana State Univ Med Ctr / HIV Outpatient Clinic	New Orleans	Louisiana
United States	Beth Israel Med Ctr	New York	New York
United States	Harlem Hosp Ctr	New York	New York
United States	Univ of Med & Dentistry of New Jersey	Newark	New Jersey
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	Saint Josephs Comprehensive Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
PPD

Countries where clinical trial is conducted

United States,  Puerto Rico,