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	Treatment or Intervention	Phase
HIV Infections	Drug: Indinavir sulfate  Drug: Ritonavir  Drug: Stavudine  Drug: Didanosine	Phase III

Further Study Details: 

Expected Total Enrollment:  200

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States
      Univ of Southern California, Los Angeles,  California,  90033,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
Florida
      Saint Josephs Comprehensive Research Institute, Tampa,  Florida,  33607,  United States
      North Broward Hosp District / HIV Clinical Research, Fort Lauderdale,  Florida,  33311,  United States
Louisiana
      Louisiana State Univ Med Ctr / HIV Outpatient Clinic, New Orleans,  Louisiana,  70112,  United States
Massachusetts
      JSI Research and Training Institute, Boston,  Massachusetts,  02210,  United States
New Jersey
      Univ of Med & Dentistry of New Jersey, Newark,  New Jersey,  07103,  United States
New York
      Univ of Rochester Med Ctr, Rochester,  New York,  14642,  United States
      Harlem Hosp Ctr, New York,  New York,  10037,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
Tennessee
      Vanderbilt Univ School of Medicine, Nashville,  Tennessee,  37212,  United States
Texas
      Univ of Texas Southwestern Med Ctr, Dallas,  Texas,  75390,  United States
Puerto Rico
      Ponce Univ Hosp, Ponce,  00731,  Puerto Rico
      Univ of Puerto Rico School of Med, Rio Piedras,  00935,  Puerto Rico

Study ID Numbers:  312A; BMS 2000
Record last reviewed:  June 2001
Last Updated:  October 13, 2004
Record first received:  October 10, 2000
ClinicalTrials.gov Identifier:  NCT00006397
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08