GW873140 In Combination With Combivir In HIV Infected Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00104429
• Date of registration: 28/02/2005
• Prospective Registration: No
• Primary sponsor: ViiV Healthcare
• Public title: GW873140 In Combination With Combivir In HIV Infected Subjects
• Scientific title: A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults
• Date of first enrolment: January 2005
• Target sample size: 125
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00104429
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, France, Germany, Italy, Portugal, Spain, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials, MD
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- HIV infected subjects.

- Females must be of either non-childbearing age, or have a negative pregnancy test.

- All subjects participating in this study should be counseled on the practice of safe
sex using a proven double barrier method of contraception throughout the study.

- Screening lab result of plasma HIV-1 RNA greater than or equal to 10,000 copies/mL and
CD4 cell count greater than or equal to 100 cells/mm3.

- Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at
screening visit.

- Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance
test at screening visit.

- Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a
protease inhibitor (PI) or a nucleoside reverse transcriptase inhibitor/nucleotide
reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of
therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).

- Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor
(experimental or approved) is not allowed.

- Be able to understand and follow with protocol requirements, instructions and
protocol-stated restrictions.

- Signed and dated written informed consent prior to study entry.

Exclusion criteria:

- Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test
at screening.

- Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test
at screening visit.

- Active Class C AIDS-defining illness.

- Laboratory abnormalities at screen.

- Significant blood loss prior to study start.

- Pregnant or breastfeeding women.

- Additional qualifying criteria to be determined by the physician.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Infection, Human Immunodeficiency Virus I

HIV Infection

Intervention(s)

Drug: GW873140

Drug: Combivir

Primary Outcome(s)

Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12

Secondary Outcome(s)

- Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.

Secondary ID(s)

102881

Source(s) of Monetary Support

Please refer to primary and secondary sponsors