Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01989910
• Collaborator: (none)
• Enrollment: 107
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.

Condition or Disease	Intervention/Treatment	Phase
HIV-1 Infection	Drug: Raltegravir; Drug: Efavirenz	Phase 4

Detailed Description

A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Raltegravir Raltegravir 400mg oral twice daily	Drug: Efavirenz; Efavirenz 600mg oral at bedtime; Other Names: Stocrit
Active Comparator: Efavirenz Efavirenz 600mg oral at bedtime	Drug: Raltegravir; Raltegravir 400mg oral twice daily; Other Names: Isentress

Outcome Measures

Primary Outcome Measures

1. The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. [At week 48 of both arms]

   Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.

Secondary Outcome Measures

1. The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. [At week 48 of both arms]

   Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms.

2. The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms. [At week 48 of both arms.]

   The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.

3. The Proportion of Treatment Failure at Week 48 for Both Arms. [At week 48 of both arms]

   The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are infected with HIV-1

• Patients have not yet received any treatment for HIV

• Patients with HIV viral RNA exceeds 5000 copies per ml

• Ages at least 20 years

Exclusion Criteria:

• Patients with acute or decompensated chronic hepatitis

• Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range

• Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range

• Patients with any medical disorder that the use of study medications is contraindicated

• Pregnant or breastfeeding women

• Patients who are lack of expectation to maintain assigned study medication during study period

• Patients who have received therapy with investigational drugs in the previous 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Infectious Diseases, Taipei Veterans General Hospital	Taipei		Taiwan	11217

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

• Principal Investigator: Wing Wai Wong, MD, Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3. Erratum in: Lancet. 2009 Dec 19-2010 Jan 1;374(9707):2054. Lancet. 2009 Sep 5;374(9692):786.
• Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
• Young B, Vanig T, Dejesus E, Hawkins T, St Clair M, Yau L, Ha B, Shield Study Team. A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naïve HIV-1-infected patients: 48-week results of the SHIELD trial. HIV Clin Trials. 2010 Sep-Oct;11(5):260-9. doi: 10.1310/hct1105-260.

• Responsible Party: Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT01989910
• Other Study ID Numbers: MSD-MISP-39299; TVGH-IRB-2013-07-030B
• First Posted: Nov 21, 2013
• Last Update Posted: Feb 25, 2019
• Last Verified: Oct 1, 2018

• Keywords provided by Taipei Veterans General Hospital, Taiwan: Efavirenz; Raltegravir; Combination antiretroviral therapy
• Additional relevant MeSH terms: Infections; Efavirenz; Raltegravir Potassium

Study Results

Participant Flow

Arm/Group Title	Raltegravir	Efavirenz
Arm/Group Description	Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
Period Title: Overall Study
STARTED	53	54
COMPLETED	51	54
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Raltegravir	Efavirenz	Total
Arm/Group Description	Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily	Total of all reporting groups
Overall Participants	51	54	105
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	31	33	32
Sex: Female, Male (Count of Participants)
Female	1 2%	2 3.7%	3 2.9%
Male	50 98%	52 96.3%	102 97.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	51 100%	54 100%	105 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Baseline VL >100,000 copies/mL (Count of Participants)
Count of Participants [Participants]	27 52.9%	28 51.9%	55 52.4%

Outcome Measures

1. Primary Outcome

Title	The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
Description	Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.
Time Frame	At week 48 of both arms

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Raltegravir	Efavirenz
Arm/Group Description	Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
Measure Participants	51	54
Count of Participants [Participants]	41 80.4%	36 66.7%

2. Secondary Outcome

Title	The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.
Description	Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms.
Time Frame	At week 48 of both arms

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Raltegravir	Efavirenz
Arm/Group Description	Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
Measure Participants	51	54
Count of Participants [Participants]	41 80.4%	36 66.7%

3. Secondary Outcome

Title	The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.
Description	The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.
Time Frame	At week 48 of both arms.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	The Proportion of Treatment Failure at Week 48 for Both Arms.
Description	The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.
Time Frame	At week 48 of both arms

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Raltegravir	Efavirenz
Arm/Group Description	Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime	Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
Measure Participants	51	54
Count of Participants [Participants]	2 3.9%	2 3.7%

Adverse Events

Arm/Group Title	Raltegravir		Efavirenz
Arm/Group Description	Raltegravir 400mg oral twice daily Efavirenz: Efavirenz 600mg oral at bedtime		Efavirenz 600mg oral at bedtime Raltegravir: Raltegravir 400mg oral twice daily
All Cause Mortality
	Raltegravir		Efavirenz
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/54 (0%)
Serious Adverse Events
	Raltegravir		Efavirenz
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	Raltegravir		Efavirenz
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/51 (7.8%)		10/54 (18.5%)
Blood and lymphatic system disorders
Anemia	2/51 (3.9%)		0/54 (0%)
Eosinophilia	0/51 (0%)		1/54 (1.9%)
Gastrointestinal disorders
Swallowing Difficulties	0/51 (0%)		1/54 (1.9%)
Metabolism and nutrition disorders
Hypertriglycemia	1/51 (2%)		0/54 (0%)
Musculoskeletal and connective tissue disorders
CK Elevation	1/51 (2%)		0/54 (0%)
Nervous system disorders
Insomnia	0/51 (0%)		6/54 (11.1%)
Skin and subcutaneous tissue disorders
Rash	0/51 (0%)		2/54 (3.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.