Clinical Trial to Assess the Security of the Dose Reduction of Ritonavir in HIV-Infected Patients in Treatment With Tipranavir/Ritonavir 500/200 mg Every 12 Hours

NCT00607958 | Completed Phase 4

• 1 other identifier: TPVRTV_500100_IQ
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Tipranavir is a drug with a high antiretroviral activity, also in presence of major mutations in the protease gene. However, its necessity of being co-administered with 400 mg of ritonavir daily, limits its efficacy for the treatment of HIV-infected patients, due to the high incidence of gastrointestinal adverse events. Nevertheless, tipranavir plasma though concentrations were higher than the proposed minimum effective concentration for patients with previous experience with protease inhibitors (PI) in half of patients treated with tipranavir/ritonavir at 500/100 mg dose every 12 hours. Furthermore, when the number of mutations in the protease gene is limited, there are no differences in the reduction of the viral load between patients treated with tipranavir/ritonavir at 500/200 mg and 500/100 mg every 12 hours. At last, the efficacy of tipranavir treatment has been more closely related with the inhibition quotient (IQ) than with concentrations considered isolated. Considering the previous arguments, it can be hypothesized that, basing in every subject IQ, it could be possible to identify those patients HIV-infected in treatment with tipranavir/ritonavir at 500/200 mg every 12 hours that could take advance of the reduction of ritonavir to 100 mg every 12 hours, without compromising the viral replication control. This strategy could improve the tolerability to the treatment, what could result in a better adherence and less proportion of treatment abandon due to this reason

Conditions

HIV Infections

Keywords

Tipranavir; ritonavir; dose reduction; inhibitory quotient

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with viral load <50 copies/mL

  Basal, week 2, week 4, week 8, week 12 week 24, week 36 and week 48.

Secondary Outcomes (7)

• Proportion of patients that show a tipranavir IQ >60 while treated with tipranavir/ritonavir 500/200 mg every 12 hours

  Screening

• Proportion of patients that maintain a tipranavir IQ >=40 while treated with tipranavir/ritonavir 500/100 mg every 12 hours

  Basal, week 2, week 4, week 8, week 12 week 24, week 36 and week 48.

• Change in CD4 lymphocytes count after 24 and 48 weeks' follow-up

  Week 24 and week 48

• Incidence and severity of adverse events after 24 and 48 weeks' follow-up

  Week 24 and week 48

• Change in lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides) after 24 and 48 weeks' follow-up

  Week 24 and week 48

Study Arms (1)

1

EXPERIMENTAL

dose reduction

Drug: tipranavir/ritonavir (dose reduction)

Interventions

tipranavir/ritonavir (dose reduction) DRUG

tipranavir/ritonavir 500/100 BID

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age +=18 years.
• HIV-infected patients.
• Stable antiretroviral treatment including tipranavir/ritonavir 500/200 every 12 hours for at least 4 weeks.
• HIV viral load \<50 copies/mL for at least 12 weeks.
• Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
• Tipranavir IQ +=60.
• Subject able to follow the treatment period.
• In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
• Signature of the informed consent.

You may not qualify if:

• AIDS-defining illness in the last 4 weeks.
• Suspicion of unsuitable antiretroviral treatment compliance.
• In women, pregnancy or breastfeeding.
• Record or suspicion of incapability to cooperate as appropriate.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir; Ritonavir; Drug Tapering

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Therapy; Therapeutics

Study Officials

• Molto Jose, MD,PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

ES (1)