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

Status unconfirmed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00006397

Run by

PPD Development, LP

People needed

200

Starts

2000-08-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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