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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Ritonavir
Stavudine
Didanosine
Sponsored by
PPD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Sex Factors, Ritonavir, Indinavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • East Bay AIDS Ctr
  • Univ of Southern California
  • UCLA CARE Ctr
  • North Broward Hosp District / HIV Clinical Research
  • Saint Josephs Comprehensive Research Institute
  • Louisiana State Univ Med Ctr / HIV Outpatient Clinic
  • JSI Research and Training Institute
  • Univ of Med & Dentistry of New Jersey
  • Beth Israel Med Ctr
  • Harlem Hosp Ctr
  • Univ of Rochester Med Ctr
  • Vanderbilt Univ School of Medicine
  • Univ of Texas Southwestern Med Ctr
  • Ponce Univ Hosp
  • Univ of Puerto Rico School of Med

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 10, 2000
Last Updated
June 23, 2005
Sponsor
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT00006397
Brief Title
Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs
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 Type
Interventional

2. Study Status

Record Verification Date
June 2001
Overall Recruitment Status
Unknown status
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
PPD

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Sex Factors, Ritonavir, Indinavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Univ of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
North Broward Hosp District / HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Saint Josephs Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
JSI Research and Training Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02210
Country
United States
Facility Name
Univ of Med & Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Vanderbilt Univ School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Ponce Univ Hosp
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Univ of Puerto Rico School of Med
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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