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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PPD
• Treatments: Didanosine; Indinavir; Reverse Transcriptase Inhibitors; Ritonavir; Stavudine

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.