Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

NCT01275625 | Completed Phase 4 Results

• 1 other identifier: A4001101
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

HIV

Keywords

maraviroc; naive; hiv; zidovudine; lamivudine; combivir; Clade A

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.

  Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.

  48 weeks

Secondary Outcomes (10)

• Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.

  Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48

• Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.

  Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48

• Virologic Response: Rate of Virologic Failure at Week 48.

  48 weeks

• Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)

  Week 48

• Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)

  Week 48

Study Arms (1)

Treatment

EXPERIMENTAL

Single arm study of combivir and maraviroc for 48 weeks

Drug: HIV therapy

Interventions

HIV therapy DRUG

Combivir one tablet BD with maraviroc 300mg BD for 48 weeks

Also known as: Selzentry, Celsentri

Treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Previously treated with anti-HIV medicines.
• Hepatitis B co-infection.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (8)

Regional Center on AIDS and Infectious Diseases Prophylaxis and Control

Krasnoyarsk, 660049, Russia

Location

Federal scientific and methodological center on AIDS prophylaxis and control

Moscow, 105275, Russia

Location

Moscow regional center on AIDS and infectious diseases prophylaxis and control

Moscow, 129110, Russia

Location

Regional Center on AIDS and Infectious Diseases Prophylaxis and Control

Nizhny Novgorod, 603005, Russia

Location

Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control

Saint Petersburg, 190103, Russia

Location

Federal State Institution Republican clinical infectious hospital of Roszdrav

Saint Petersburg, 196645, Russia

Location

Smolensk Center on AIDS and infectious diseases prophylaxis and control

Smolensk, 214006, Russia

Location

Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control

Volgograd, 400040, Russia

Location

Related Publications (1)

• Lewis ME, Jubb B, Simpson P, Lopatukhin A, Kireev D, Bobkova M, Craig C, van der Ryst E, Westby M, Butler SL. Highly prevalent Russian HIV-1 V3-loop sequence variants are susceptible to maraviroc. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211025156. doi: 10.1177/20402066211025156.

  PMID: 34160290 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 12, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2013
• Last Updated: March 3, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-01

Locations

RU (8)