Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients (RAN)
This study has been completed.
Sponsor:
The University of Texas Health Science Center, Houston
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00762892
First received: September 26, 2008
Last updated: December 19, 2014
Last verified: December 2014
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: December 19, 2014
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
HIV Infections |
| Interventions: |
Drug: Raltegravir and truvada Drug: Atazanavir, Norvir and Truvada |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| approached patients HIV positive, naive to therapy, single site, English and Spanish speaking/writing. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Raltegravir |
Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily |
| Atazanavir |
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily |
Participant Flow: Overall Study
| Raltegravir | Atazanavir | |
|---|---|---|
| STARTED | 14 | 14 |
| COMPLETED | 9 | 8 |
| NOT COMPLETED | 5 | 6 |
| Lost to Follow-up | 2 | 5 |
| Withdrawal by Subject | 0 | 1 |
| Death | 1 | 0 |
| Pregnancy | 1 | 0 |
| Incarceration | 1 | 0 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Raltegravir |
Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily |
| Atazanavir |
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily |
| Total | Total of all reporting groups |
Baseline Measures
| Raltegravir | Atazanavir | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
14 | 14 | 28 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 14 | 28 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: year] Mean (Standard Deviation) |
40.7 (11) | 38.8 (10) | 39.8 (10.4) |
|
Gender
[units: participants] |
|||
| Female | 7 | 3 | 10 |
| Male | 7 | 11 | 18 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 14 | 14 | 28 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Change From Baseline in CD4 Count at 48 Weeks [ Time Frame: Baseline and 48 weeks ] |
| 2. Primary: | Change From Baseline in Log HIV Viral Load at 48 Weeks [ Time Frame: Baseline and 48 weeks ] |
| 3. Secondary: | Change From Baseline in Lipids at 48 Weeks [ Time Frame: Baseline and 48 weeks ] |
| 4. Secondary: | Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks [ Time Frame: Baseline and 48 weeks ] |
| 5. Secondary: | Change From Baseline in Homocysteine at 6 Months [ Time Frame: Baseline and 48 weeks ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Limitations are the relatively small sample size and loss to follow-up. Medical records of patients that were lost to follow up was reviewed to ensure that no SAE occurred. We also attempted multiple times to contact patients. |
More Information
Certain Agreements:
Results Point of Contact:
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT 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. |
Results Point of Contact:
Name/Title: Tanvir Bell, MD
Organization: UT Health Science Center Houston
phone: 713-500-6759
e-mail: Tanvir.K.Bell@uth.tmc.edu
Organization: UT Health Science Center Houston
phone: 713-500-6759
e-mail: Tanvir.K.Bell@uth.tmc.edu
| Responsible Party: | Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00762892 History of Changes |
| Other Study ID Numbers: |
raltegravir atazanavir naive |
| Study First Received: | September 26, 2008 |
| Results First Received: | December 19, 2014 |
| Last Updated: | December 19, 2014 |
| Health Authority: | United States: Institutional Review Board |