Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01776996
  4. Details
NCT01776996 Clinical Trial

An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:
An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01776996
Other study ID # 116278
Secondary ID
Status No longer available
Phase N/A
First received January 24, 2013
Last updated April 4, 2017

Study information
Verified date April 2017
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

- Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.

- Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria.

- Subject agrees to the specified study procedures.

Exclusion Criteria:

- Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.

- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

- Contra-indications to use of maraviroc as described in the Investigator Brochure.

- Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Continued Access Arm
All subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day.

Locations
Country Name City State
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Rosario Santa Fe
Belgium GSK Investigational Site Brussels
Belgium GSK Investigational Site Gent
Belgium GSK Investigational Site Leuven
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Modena
Poland GSK Investigational Site Bydgoszcz
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site N.Novgorod
Russian Federation GSK Investigational Site Saint-Petersburg
Russian Federation GSK Investigational Site Smolensk
Russian Federation GSK Investigational Site St. Petersburg
South Africa GSK Investigational Site Bloemfontein
South Africa GSK Investigational Site Dundee
South Africa GSK Investigational Site Gauteng
South Africa GSK Investigational Site Port Elizabeth
South Africa GSK Investigational Site Port Elizabeth Eastern Cape
South Africa GSK Investigational Site Pretoria
South Africa GSK Investigational Site Pretoria North
South Africa GSK Investigational Site Soweto Gauteng
South Africa GSK Investigational Site Westdene
Switzerland GSK Investigational Site Bern
Switzerland GSK Investigational Site Lugano
Switzerland GSK Investigational Site Zuerich

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Belgium,  Italy,  Poland,  Russian Federation,  South Africa,  Switzerland, 

See also
  Status Clinical Trial Phase
Completed NCT01425099 - Drug Interaction Study Between Dolutegravir and Prednisone Phase 1
Completed NCT01209117 - A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435 Phase 1
Completed NCT03231943 - GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers Phase 1
Terminated NCT01195974 - A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects. Phase 1
Completed NCT02893488 - Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet Phase 1
Terminated NCT01199731 - Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection Phase 2
Completed NCT01449929 - Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects Phase 3
Active, not recruiting NCT02951052 - Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults Phase 3
Completed NCT01231516 - A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults Phase 3
Completed NCT02273947 - Food Effect Study With BMS-955176 Phase 1
Completed NCT00071760 - Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects Phase 2
Completed NCT02539576 - Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects Phase 1
Completed NCT01967771 - Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects Phase 1
Completed NCT00774735 - GSK1349572 Drug Interaction Study With Protease Inhibitors Phase 1
Completed NCT01077635 - PENTA Fosamprenavir Study N/A
Completed NCT00386347 - A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects. Phase 1
Completed NCT00945282 - Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults. Phase 2
Terminated NCT02576119 - A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects Phase 1
Completed NCT02277600 - A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI) Phase 1
Completed NCT01077557 - Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status N/A