Status:
COMPLETED
Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Comprehensive International Program of Research on AIDS
Conditions:
HIV Infections
Herpesvirus 2, Human
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV tr...
Detailed Description
Women coinfected with HIV and HSV-2 experience more genital herpes outbreaks than women infected only with HSV-2. Frequent or recurrent herpes outbreaks in women infected with HIV can lead to an incre...
Eligibility Criteria
Inclusion
- HIV-1 infected
- HSV-2 infected
- Initiating HAART per Peruvian guidelines for the first time at study entry
- CD4 count less than 200 cells/mm3 OR CD4 count less than 350 cells/mm3 AND viral load greater than 55,000 copies/ml within 30 days prior to study entry
- Does not intend to move outside of greater metropolitan Lima, Peru area for the duration of the study
- Willing to follow all study requirements
- Willing to provide written informed consent
Exclusion
- Prior HAART
- History of adverse reaction to acyclovir, famciclovir, or valacyclovir
- Unwilling to take acyclovir, famciclovir, or valacyclovir
- History of seizures
- Renal insufficiency, defined as serum creatinine greater than 2 mg/dl or a creatinine clearance less than 50 ml/min
- Treatment for a serious medical condition 14 days prior to study entry. Patients with chronic, acute, or recurrent opportunistic infections (OIs) who have completed therapy and are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
- Clinically unstable and untreated OIs or tumors within 14 days prior to study entry. More information on this criterion can be found in the protocol.
- Clinically unstable and untreated bacterial sexually transmitted diseases (STDs) within 14 days prior to study entry. More information on this criterion can be found in the protocol.
- Radiation therapy or systemic chemotherapy within 45 days prior to study entry. Participants who underwent systemic chemotherapy for the treatment of Kaposi's sarcoma (KS) if it was completed prior to study entry are not excluded.
- Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. Patients who received a tapering course of corticosteroids as acute therapy for Pneumocystis carinii pneumonia (PCP) or are receiving inhaled or nasal fluticasone are not excluded.
- Current drug or alcohol use that, in the investigator's opinion, may interfere with the study
- Vomiting or inability to swallow medications
- Involuntarily incarcerated in a correctional facility, prison, or jail or being detained for the treatment of either a psychiatric or infectious disease
- Grade 2 or 3 high-grade cervical dysplasia and cervical neoplasia within 6 months prior to study entry
- Any other condition that, in the investigator's opinion, may interfere with the study
- Pregnancy
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00371592
Start Date
September 1 2006
End Date
January 1 2009
Last Update
September 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IMPACTA - San Miguel CIPRA Project 1 CRS
San Miguel, Lima region, Peru, 32