Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials

HIV Infections Clinical Trial

Official title:

An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514098
• Other study ID #: MTN-015
• Secondary ID: 5UM1AI0686331052
• Status: Completed
• Start date: August 25, 2008
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2021
• Source: Microbicide Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A new approach to HIV prevention currently being studied includes the use of topical microbicides and orally administered anti-HIV drugs. The purpose of this study is to better understand the impact of microbicides in women who are diagnosed with HIV-1 during participation in previous microbicide trials.

Description:

It is necessary to monitor HIV over long periods of time in order to better understand the impact of microbicides and anti-HIV drugs on the progression of HIV infection in those who become infected or are unknowingly already infected while receiving these drugs. The purpose of this study is to determine the effects of microbicides or oral anti-HIV drugs over time in HIV infected women who were previously enrolled in other microbicide trials.

The study will remain open to accrual for the duration of MTN funding, and will use two follow-up visit schedules, one based on the date of diagnosis in the parent study, and one based on the initiation of antiretroviral treatment (ART). Participants who have not initiated ART at the time of enrollment in this study will follow the schedule based on the date of diagnosis. Participants who have already begun ART at the time of enrollment will follow the schedule based on the date of ART initiation. Individuals enrolled with a starting date based on the date of ART initiation will have their first follow-up visit at Week 2 before resuming the rest of the schedule. On both schedules, follow-up visits occur at Months 1, 3, and 6 and every 6 months thereafter. Interim visits may be performed at any time during follow-up, and participants will be asked to attend a final study visit prior to their termination from the study. Participants may enroll any time after their HIV diagnosis and can leave the study at any time.

A physical exam; medical and medication history assessment; blood and urine collection; and pelvic, cervicovaginal lavage, and vaginal swab sampling will occur at all visits. A behavioral assessment will occur at select visits, and adherence and social harms assessments will occur at most visits. Sexually transmitted infection risk reduction/contraception and HIV-1 secondary counseling will occur at most visits. In addition, condoms will be provided at all visits to reduce further HIV transmission. ART will not be provided by this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of HIV-1 infection during participation in any Microbicide Trials Network (MTN) clinical trial (including HPTN 035 and HPTN 059), according to the HIV testing algorithm of the parent MTN trial

• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, makes participation in the study unsafe or interferes with the study

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Malawi	College of Med. JHU CRS	Blantyre
Malawi	University of North Carolina Lilongwe	Lilongwe
South Africa	Botha's Hill CRS	Durban	KwaZulu-Natal
South Africa	CAPRISA eThewkini	Durban	KwaZulu Natal
South Africa	Isipingo CRS	Durban	KwaZulu-Natal
South Africa	Overport CRS	Durban	KwaZulu-Natal
South Africa	R. K. Khan CRS	Durban
South Africa	South African Medical Research Council, Tongaat	Durban	KwaZulu Natal
South Africa	Umkomaas CRS	Durban	KwaZulu-Natal
South Africa	Verulam CRS	Durban	KwaZulu-Natal
South Africa	CAPRISA- The Aurum Institute	Johannesburg	Guateng
South Africa	Perinatal HIV Research Unit (HPRU)	Johannesburg	Soweto
South Africa	Wits Reproductive Health Institute (WRHI)	Johannesburg	Gauteng
Uganda	Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS	Kampala
Zambia	Kamwala Clinic CRS	Kamwala
Zimbabwe	Seke South CRS	Chitungwiza
Zimbabwe	Spilhaus CRS	Harare
Zimbabwe	UZ-UCSF HIV Prevention Trials Unit	Harare	Chitungwiza

Sponsors (4)

Lead Sponsor	Collaborator
Microbicide Trials Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Malawi,  South Africa,  Uganda,  Zambia,  Zimbabwe, 

References & Publications (3)

Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015 and MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral The — View Citation

Riddler SA, Husnik M, Gorbach PM, Levy L, Parikh U, Livant E, Pather A, Makanani B, Muhlanga F, Kasaro M, Martinson F, Elharrar V, Balkus JE; MTN-015 Protocol Team for the Microbicide Trials Network. Long-term follow-up of HIV seroconverters in microbicid — View Citation

Riddler SA, Husnik M, Ramjee G, Premrajh A, Tutshana BO, Pather A, Siva S, Jeenarain N, Nair G, Selepe P, Kabwigu S, Palanee-Phillips T, Panchia R, Mhlanga F, Levy L, Livant E, Patterson K, Elharrar V, Balkus J. HIV disease progression among women followi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV-1 drug resistance mutation evaluation	To evaluate the prevalence and persistence of HIV-1 drug resistance mutations in plasma and/or genital tract specimens after HIV-1 seroconversion using both standard and sensitive methods in specific subgroups of seroconverters.	Total duration of follow up
Primary	HIV disease progression comparison	To compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.	12 months
Secondary	HIV disease progression comparison	To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.	Total duration of follow up
Secondary	Virologic and immunologic response comparison	To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.	Total duration of follow up
Secondary	HIV-1 drug resistance profile comparison	To compare the HIV-1 drug resistance profile, among antiretroviral therapy recipients at the time of virologic failure in participants assigned to an active agent versus placebo/control participants.	Total duration of follow up
Secondary	Sexual behavior and partnership status changes	To describe post seroconversion changes in sexual behaviors and partnership status of participants.	Total duration of follow up

External Links

•   Click here for the Microbicide Trials Network Web site