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

Sponsor

PPD (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00006397

Collaborator

(none)

200

Enrollment

Locations

13.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Ritonavir Drug: Stavudine Drug: Didanosine	Phase 3

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay AIDS Ctr	Berkeley	California	United States	94705
2	Univ of Southern California	Los Angeles	California	United States	90033
3	UCLA CARE Ctr	Los Angeles	California	United States	90095
4	North Broward Hosp District / HIV Clinical Research	Fort Lauderdale	Florida	United States	33311
5	Saint Josephs Comprehensive Research Institute	Tampa	Florida	United States	33607
6	Louisiana State Univ Med Ctr / HIV Outpatient Clinic	New Orleans	Louisiana	United States	70112
7	JSI Research and Training Institute	Boston	Massachusetts	United States	02210
8	Univ of Med & Dentistry of New Jersey	Newark	New Jersey	United States	07103
9	Beth Israel Med Ctr	New York	New York	United States	10003
10	Harlem Hosp Ctr	New York	New York	United States	10037
11	Univ of Rochester Med Ctr	Rochester	New York	United States	14642
12	Vanderbilt Univ School of Medicine	Nashville	Tennessee	United States	37212
13	Univ of Texas Southwestern Med Ctr	Dallas	Texas	United States	75390
14	Ponce Univ Hosp	Ponce		Puerto Rico	00731
15	Univ of Puerto Rico School of Med	Rio Piedras		Puerto Rico	00935