Clinical trial NCT00006397: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: Didanosine
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Sex Factors
Ritonavir
Indinavir
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Los Angeles
country: United States
facility: Univ of Southern California
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Ctr
state: California
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District / HIV Clinical Research
state: Florida
city: Tampa
country: United States
facility: Saint Josephs Comprehensive Research Institute
state: Florida
city: New Orleans
country: United States
facility: Louisiana State Univ Med Ctr / HIV Outpatient Clinic
state: Louisiana
city: Boston
country: United States
facility: JSI Research and Training Institute
state: Massachusetts
city: Newark
country: United States
facility: Univ of Med & Dentistry of New Jersey
state: New Jersey
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Harlem Hosp Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Nashville
country: United States
facility: Vanderbilt Univ School of Medicine
state: Tennessee
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr
state: Texas
city: Ponce
country: Puerto Rico
facility: Ponce Univ Hosp
city: Rio Piedras
country: Puerto Rico
facility: Univ of Puerto Rico School of Med
Study officials:
References: