Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) 500 mg/200 mg BID IN a racially and Gender diverse HIV positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring (TDM). The SPRING study is an open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy - SPRING study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. HIV-1 infected adults, men and women >=18 years of age.
2. Three-class (NRTI, NNRTI, and PI) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI (on the screening resistance testing).
3. CD4+ T lymphocyte count =50 cells/mm3.
4. HIV-1 viral load >=1,000 copies/mL at screening .
5. The ARV study treatment regimen must consist of new TPV/r in combination with an OBR of 2-4 agents of the following: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, an Expanded Access Program (EAP) investigational agent (Section 3.3).
In total, patients are to have an ARV study treatment regimen consisting of at least 3
agents (TPV/r and at least two OBRs).
The following considerations must be applied in construction of the OBR:
• At least one of the OBR agents must be new (defined as first time patient use).
• If two N(t)RTIs are used for the OBR, at least one of the RTIs must be new to the
patient with a maximal response” on the Virco resistance analysis report. The
other N(t)RTIs in the regimen may have either a maximal or reduced response”
on the Virco resistance analysis report.
• If either new ENF and/or potentially approved new agents (e.g., raltegravir and
maraviroc) are used for the OBR, the N(t)RTIs may have either a maximal or
reduced response” on the Virco resistance analysis report. Raltegravir and
maraviroc may be accessed commercially if approved or through EAPs where
available.
• N(t)RTIs that are classified as having a minimal or resistant response” on the
Virco resistance analysis report may be used but will not count as one of the 2-4
active agents required to be in the OBR.
• For patients who had previously taken lamivudine (3TC) or emtricitabine (FTC),
neither of these drugs is considered as sensitive regardless of the genotype
report.
If previously taken, either 3TC or FTC may be included in the OBR but will not
count as one of the 2-4 agents required to be in the OBR.
Patients co-infected with HBV already treated at screening with anti-HBV drugs which
have also an anti-HIV activity (lamivudine, emtricitabine, tenofovir) should remain on
these drugs during the trial. These drugs, however, will not be counted as active
anti-HIV drugs in the background regimen.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known hypersensitivity to any of the ingredients to the tipranavir or ritonavir formulations.
2. ARV medication naïve.
3. Genotypic resistance to TPV (defined as a TPV mutation score >7).
4. Prior tipranavir use.
5. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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