Activity and Safety of SCH 532706 in HIV-1 Infected Subjects

To evaluate the virologic activity of SCH 532706 coadministered with ritonavir in CCR5-tropic HIV-infected individuals.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000171415

Enrollment

Registered

2007-03-15

Start date

2007-03-06

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to assess the virologic activity, safety, tolerability and pharmacodynmaic profile of SCH 532706 when codminstered with a dose of Ritonavir that could be observed during the treatment of patients with HIV.

Interventions

This is a single-site, fixed sequence, open label, evaluation of SCH 532706 plus ritonavir. Each patient will receive 20 doses of SCH 532706 and 10 doses of ritonavir over 10 days. SCH 532706 60mg administered twice daily as an oral solution (at 2mg/mL) Ritonavir 100mg will be administered once daily as a single capsule. Each patient will be given SCH 532706 morning (AM) and night and Ritonavir each morning (AM) for 10 days.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Documented HIV infection* Must have a BMI of between 19 to 35 inclusive* Must have CCR5 tropism only.

Exclusion criteria

* Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding* Subject's with history of a seizure disorder* Subject with a mental instability.

Outcome results