Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
PPD
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00006397
First received: October 10, 2000
Last updated: June 23, 2005
Last verified: June 2001
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Stavudine Drug: Didanosine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006397
Locations
| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| North Broward Hosp District / HIV Clinical Research | |
| Fort Lauderdale, Florida, United States, 33311 | |
| Saint Josephs Comprehensive Research Institute | |
| Tampa, Florida, United States, 33607 | |
| United States, Louisiana | |
| Louisiana State Univ Med Ctr / HIV Outpatient Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| JSI Research and Training Institute | |
| Boston, Massachusetts, United States, 02210 | |
| United States, New Jersey | |
| Univ of Med & Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| United States, Tennessee | |
| Vanderbilt Univ School of Medicine | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75390 | |
| Puerto Rico | |
| Ponce Univ Hosp | |
| Ponce, Puerto Rico, 00731 | |
| Univ of Puerto Rico School of Med | |
| Rio Piedras, Puerto Rico, 00935 | |
Sponsors and Collaborators
PPD
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006397 History of Changes |
| Other Study ID Numbers: | 312A, BMS 2000 |
| Study First Received: | October 10, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Didanosine Drug Therapy, Combination Stavudine HIV Protease Inhibitors Sex Factors |
Ritonavir Indinavir Dosage Forms Reverse Transcriptase Inhibitors Anti-HIV Agents |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Didanosine Stavudine Reverse Transcriptase Inhibitors |
Indinavir Ritonavir Anti-HIV Agents HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Protease Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013