Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.

Key facts

Study ID

NCT00034866

Run by

Boehringer Ingelheim

People needed

165

Starts

2002-04-01

Expected to finish

2002-10-01

Last updated by the study team

2005-09-20

Who can join

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

You may qualify if…

• Signed informed consent prior to trial participation.
• HIV-1 infected males or females >= 18 years of age.
• At least 3 months experience taking NRTIs, NNRTI(s), and PIs.
• Current PI-based ARV medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
• HIV-1 viral load >= 1000 copies/mL at screening.
• Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M, with not more than one of 82 A/F/T or 84V or 90M.
• Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if severity is no higher than Grade 3 GGT, Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the DAIDS Grading Scale. All laboratory values outside these limits are subject to approval by BI.
• Acceptable medical history, as assessed by the investigator, with chest X-ray and ECG within 1 year of study participation.
• Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system, such as: grapefruit or Seville oranges or their products; herbal preparations containing St. John's Wort or milk thistle, and garlic supplements.
• A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment for at least 2 months.

You may not qualify if…

• ARV medication naïve.
• Female subjects who:
• have a positive serum pregnancy test at screening or during the study
• are breast feeding
• are planning to become pregnant
• are not willing to use two barrier methods of contraception (e.g. latex condom plus spermicidal jelly/foam).
• Any active opportunistic infection within 60 days before study entry.
• Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT >Grade 1.
• Prior tipranavir use.
• Use of investigational medications within 30 days before study entry or during the trial. Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
• Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
• Use of immunomodulatory drugs (e.g. interferon, cyclosporin, hydroxyurea, interleukin-2).
• Active substance abuse.
• Inability to swallow TPV or RTV capsules.

Where it is running

• Orange County Center for Special Immunology — Fountain Valley, California, United States
• Living Hope Clinical Trials Inc. — Long Beach, California, United States
• AHF Research Center — Los Angeles, California, United States
• University of So. California / LA County USC Medical Center — Los Angeles, California, United States
• ID Care, Inc. — Los Angeles, California, United States
• Tower I.D. Medical Assoc., Inc. — Los Angeles, California, United States
• University of California, Los Angeles Medical Center — Los Angeles, California, United States
• University of California San Francisco Positive Health Program Research — San Francisco, California, United States
• Pacific Horizon Medial Group — San Francisco, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• (IDC) Research Institute — Altamonte Springs, Florida, United States
• Therafirst Medical Center — Fort Lauderdale, Florida, United States
• Jackson Medical Tower — Miami, Florida, United States
• Steinhart Medical Associates — South Miami, Florida, United States
• Hillsborough County Health Dept. — Tampa, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Atlanta VA Medical Center, Dept. of ID — Decatur, Georgia, United States
• Mercer University School of Medicine — Macon, Georgia, United States
• CORE Center, Cook County Hospital — Chicago, Illinois, United States
• Rush Presbyterian/St. Luke's Medical Center — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• HIV Outpatient Program (H.O.P.) — New Orleans, Louisiana, United States
• Phoenix Body Positive — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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