Phase 4
Completed N=77
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
Source: ClinicalTrials.gov NCT01275625 ↗Enrolled (actual)
77
Serious AEs
2.6%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks. — 77.92 Percentage of participants
Summary
One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks. |
77.92 | — |
| SECONDARY Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits. |
0.00; 7.79; 26.67; 48.68; 78.08; 83.56 | — |
| SECONDARY Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits. |
0.00; 41.56; 72.00; 89.47; 91.78; 91.78 | — |
| SECONDARY Virologic Response: Rate of Virologic Failure at Week 48. |
60; 1; 15; 1; 4; 9 | — |
| SECONDARY Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) |
165.53 | — |
| SECONDARY Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) |
8.07 | — |
| SECONDARY Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) |
-112.96 | — |
| SECONDARY Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) |
-8.59 | — |
| SECONDARY Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio. |
0.33 | — |
| SECONDARY Number of Participants With Genotypic Resistance. |
8; 5 | — |
| SECONDARY Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure. |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Over 18 years of age.
- R5 HIV infection on screening tropism test.
- Viral load >1,000 copies/mL.
- Never previously treated with anti-HIV medicines.
Exclusion Criteria
- Previously treated with anti-HIV medicines.
- Hepatitis B co-infection.
Data sourced from ClinicalTrials.gov (NCT01275625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.